Services: Strategic Consulting-Pharma

For Pharmaceutical Industry

Change Management

Change Management Support

In the pharmaceutical industry, change management is something every company deals with on a daily basis. A change and deviation management system (CMS) is a central part of the overall quality management system for drug product manufacture and is often referred to as the pharmaceutical quality system.

 

Regulatory Compliance Associates® can help you implement a CMS including the following as appropriate for the stage of the product lifecycle. Following is a representative, but not exclusive, list of reasons for change management:

  • Changes to regulatory compliance with new standards
  • Implementation of Cost Reduction Initiatives
  • New Supplier Changes
  • Upgrades to Aging Facilities
  • Change Management to Address Complaints

 

Our broad range of Pharmaceutical Strategic consulting services include:

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Risk Management: Mergers & Acquisitions

Getting the most value out of Mergers or Acquisitions requires proper upfront legwork, risk management and risk assessment.

 

risk managementIn the business press, discussions of mergers and acquisitions (M&As) invariably include percentages of deals that did not create their expected value. Failure numbers, ranging from 60–80%, are surprisingly high. Many companies seem to pursue mergers or acquisitions without a clear picture of their potential risks. A due-diligence process that’s too high-level or superficial is often to blame.

 

For example, when a life-science company considers a merger or acquisition, the due-diligence team typically looks for 483s, Warning Letters, notified-body findings, and product recalls to find any signs of potential problems with FDA. But when a deal does not deliver value, the real causes are often strategic, cultural, or technical.

 

Risk Assessment

 

Due diligence is not the same as risk management or conducting a quality assurance compliance audit. But in the life-science industry, it’s easy to confuse the two. The executives or the private-equity firm structuring the deal do not necessarily understand the companies’ operations or FDA sanctions.

 

At the same time, if a CEO or CFO is enamored with M&As as a perceived means to expand into a new business or enter a new market, the due-diligence team typically lacks the business expertise to ask the right questions or the clout to raise objections.

 

Risk Assessment Example

 

For example, Company A might want to buy Company B because of its superior sales force. Company A’s marketing department contends that sales would double; the finance department believes that redundancy would allow Company A to reduce payroll by 10%.

 

Both predictions are correct, but no one calculates the extra manufacturing capacity needed to produce a larger portfolio and volume of products. The expected value of the deal could be canceled out by unanticipated costs in another part of the organization.

 

Level of Compliance

 

The fundamental questions asked during due diligence should go beyond FDA compliance and tackle the business reasons for closing the deal. This approach requires having the right people (not necessarily those who happen to be available) on the due-diligence team.

 

Technical executives might be asked about open citations, but they’re rarely consulted about the likely costs of integrating factories, supply chains, or distribution centers—or whether these integrations can be done at all. But if integration costs more or takes longer than expected, customer relationships and product quality can suffer.

 

Checklists for Due Diligence

 

Often in a merger or acquisition, using a checklist to gouge the personalities of the two companies are not considered relevant. But stress and tensions can build when the cultures of two organizations are incompatible. The possible triggers of a poor “culture fit” are limitless: management style, risk tolerance, flexibility, talent, technology, and geography, to name a few.

 

Some life-science companies are risk-takers; others are conservative. Some are entrepreneurial; others are hierarchical. Some are obsessed with “zero incidents” quality; others have a “find a problem, fix a problem” management style. If the two cultures can’t be blended, the cost of a significant restructuring (including recruiting and hiring new executives) needs to be included in the M&A price tag.

 

Technology Due Diligence

 

Post-M&A integration is often the cause of extra, unplanned costs. For instance, a seller often ends up supporting sold-off processes or IT systems long after the deal is done. When this happens, the buyer can end up with a poorly managed function, and the seller can end up with disgruntled clients and extended costs. The deal’s stakeholders, each with different goals and agendas, need to talk to each other. External stakeholders can also be drawn into the due-diligence process to reduce such risks.

 

Transition services agreements (TSAs) should be drawn up carefully to protect buyers and sellers from value destruction. For the buyer, a TSA might specify that the seller’s employees will be available to talk to regulatory authorities during the integration time period. For the seller, the TSA might detail roles and responsibilities for the sold business or division. A key executive or consultant should ensure that TSAs are followed and that the buyer takes over on schedule.

 

Commercial Due Diligence

 

Any life-science company considering a merger or acquisition should consider the following five steps to ensure that its due-diligence process helps manage business risks and prevent value destruction.

 

FDA Compliance

 

Put the right people on the team. You have to be compliant with your notified bodies at any moment in time. A life-sciences company typically has multiple locations, some in other countries, as well as complex supply-and-distribution operations. The time available to understand compliance while making the deal value can be short. The due-diligence team therefore should be structured to quickly obtain real-world answers to fundamental questions.

 

This means including experts who can look at limited data and draw reasonable conclusions about areas such as: manufacturing, product portfolios, supplier relationships, IT capabilities, R&D and engineering, marketing and sales, and environmental compliance. A quality assurance specialist cannot cover all this ground alone. Perhaps most important, the team needs a senior executive who has the power to champion the right answer for the deal, even when that answer is “no.”

 

Risk Analysis Process

 

Consider the following example. A US company wanting to acquire a high-growth product line made a play for a successful company headquartered in Australia. The rewards matched the company’s objectives: revenue from sales outside the US would jump from 15 to 40%.

 

However, the risks would be just as great: registrations and patents would require global management, and the success of the venture depended on keeping the seller’s key people and infrastructure.

 

Technical Risk Assessment

 

The-due-diligence team included the COO as well as senior people from manufacturing, finance, legal, quality assurance, business development, and R&D, and an independent consultant to question assumptions. In addition to working with a virtual data room, the team spent two days interviewing seven of the seller’s top executives and one day touring the main production facility.

 

The team included a senior executive who would be in charge of the postmerger integration crucial to future revenue and earnings. Because the due-diligence team had the right people, the process contributed significantly to the immediate and long-term success of the acquisition.

 

Risk Evaluation

 

Ask the right questions. In many ways, due diligence is a detective’s game: the analysts need to look at clues (often from only partial data) and solve the mystery by defining the business case for the merger or acquisition, identifying the ways each facility or function would contribute to (or detract from) the realization of the business benefits, and pinpointing risks to processes, functions, or the enterprise. Even companies that do a lot of deals are wise to treat each one as a new and unique experience.

 

Find weak spots and define fixes. The due-diligence team needs to address areas of risk management, such as the costs and efforts required to harmonize operations, the timetable for fixing problems, and the investment needed for postmerger integration. For example, upgrading an acquired company’s enterprise resource planning system would be expensive and resource-consuming; its costs should be acknowledged.

 

Hazards Assessment

 

Use facts to negotiate. The financial decision makers want to know of any issue large enough to stop the deal. But even problems that are not dealbreakers could be used in negotiations. The due-diligence team needs to be prepared to talk to C-suite executives, bond-rating agencies, investment bankers, and the sellers about issues, potential solutions, a course of action and as its timing and estimated price tag.

 

Regulatory Compliance

 

Bring in the regulators early. The postdeal organization should inform FDA or other appropriate regulators of plans to fix recognized problems. Regulators know that M&As can create confusion and inconsistencies, and they look for them during inspections. Even if there are no risk management problems, it is a good idea for the buyer to connect with regulators to help ensure a smooth transition. Due diligence is a strategy for risk management and return on investment. When done right, it helps ensure value creation in a merger or acquisition.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Life Science Due Diligence

Due diligence in a sentence is often mergers or acquisitions (M&A) when a team invariably did not realize the expected value creation. Failure numbers, ranging from 60-80 percent, are surprisingly high. Clearly, many companies move forward on medical device or pharma deals without a clear picture of their risks.

Due Diligence Process

A due diligence process that’s too high-level or superficial is often to blame. For example, when a life sciences company considers a merger or acquisition, the due diligence team typically looks for 483s, Warning Letters, notified body findings, and product recalls—any signs of potential problems with the FDA. But when a deal does not deliver value, the real causes are often strategic, cultural, or technical.

Financial Due Diligence

Financial due diligence is not the same as a QA compliance audit. But in the life science industry, it’s easy to confuse the two. The executives or the private equity firm structuring the deal do not necessarily “get” the companies’ operations or understand FDA sanctions. At the same time, if a CEO or CFO is enamored with M&A as a perceived means to expand into a new business or enter a new market, the due diligence team typically lacks the business expertise to ask the right questions or the clout to raise objections.

Manufacturing Capacity

For example, company A might want to buy company B because of its superior sales force. Marketing contends that sales would double; finance believes that redundancy would allow company A to reduce payroll by 10 percent. Both functions are persuasive within their own checklists for due diligence, but no one calculates the extra manufacturing capacity needed to produce a larger portfolio and volume of products. The expected value of the deal is cancelled out by unanticipated costs in another part of the organization.

FDA Compliance

The fundamental questions asked during the due diligence process should go beyond FDA compliance and tackle the business reasons for doing the deal. That requires having the right people (not necessarily those who just happen to be available) on the due diligence team from the beginning. Technical executives might be asked about open citations, but they’re rarely consulted about the likely costs of integrating two factories, or two supply chains, or two distribution centers—or whether these integrations can be done at all.

Product Quality

But if integration costs more or takes longer than expected, customer relationships and product quality can suffer. The due diligence team has to include people who can put the business case (or cases) to the test.

 

Need regulatory due diligence help? Talk to our Experts →

 

Commercial Due Diligence

Often in a merger or acquisition, commercial due diligence doesn’t gauge the “personality” of the two companies. Metrics often trump touchy feely considerations, especially when both organizations are successful in their own ways. But just imagine the stresses—to people and processes—if the cultures of two organizations are incompatible.

Organized Culture

The possible triggers of a poor company culture are nearly limitless: management style, risk tolerance, flexibility, talent, technology, and geography, to name a few. Some in life sciences are risk-takers; others are conservative. Some are entrepreneurial; others are hierarchical. Some are obsessed with “zero incidents” quality; others have a “find a problem, fix a problem” management style. These types of cultural incompatibilities are expensive.

Restructuring

If the two cultures can’t be blended, the cost of a significant restructuring (including recruiting and hiring new executives) needs to be included in the M&A price tag. The deal’s stakeholders, each with different goals and agendas, need to talk to each other.

Operational Due Diligence

Post-M&A integration is often the cause of extra, unplanned due diligence reporting. For example, a seller often is stuck supporting sold-off processes or IT systems long after the deal is done. When this happens, the buyer can end up with a poorly managed function, and the seller can end up with disgruntled people and extended costs. The deal’s stakeholders, each with different goals and agendas, need to talk to each other. External stakeholders can also be drawn into the due diligence process to reduce this risk.

Regulatory Authorities

Transition services agreements (TSAs) should be drawn up carefully to protect buyers and sellers from value destruction. For the buyer, a TSA might specify that the seller’s people will be available to talk to regulatory authorities during the integration time period.

Regulatory Due Diligence

For the seller, the TSA might detail roles and responsibilities during the regulatory due diligence for the sold business or division. A key executive or consultant should be put in place for the seller to assure TSAs are followed and that the buyer takes over on schedule, ending the seller’s responsibilities.

Technology Due Diligence

Any life sciences company considering a merger or acquisition should take these five steps to ensure that the technology due diligence due diligence process helps manage business risks and prevent value destruction.

1. Put the right people on the team.

A life sciences company typically has multiple locations, some in other countries, as well as complex supply-and-distribution operations. Also, the time available to draw up an offer can be as short as two or three weeks. The technology due diligence team should be structured to be quick in getting real-world answers to fundamental questions.

Quality Assurance

This means including experts who can look at limited data and draw reasonable conclusions about many different areas: manufacturing, product portfolios, supplier relationships, IT capabilities, R&D and engineering, marketing and sales, and environmental compliance. A QA specialist can’t cover all this ground alone. Perhaps most important, the team needs a senior executive who has the power to champion the right answer for the deal, even when that answer is NO GO.

Infrastructure

A US company wanting to acquire a high-growth product line made a play for a successful company headquartered in Australia. The rewards matched the company’s objectives: revenue from sales outside the US would jump from 15 to 40 percent. However, the risks would be just as great: registrations and patents would require global management, and the success of the venture depended on keeping the seller’s key people and infrastructure.

Manufacturing Plant

The technology due diligence team included the Chief Operating Officer, as well as senior people from manufacturing, finance, legal, QA, business development, R&D, and an independent consultant to question assumptions. In addition to working with a virtual data room, the team spent two days interviewing seven of seller’s top executives and one day touring the main production facility.

Management Information Systems

Last, but certainly not least, the team included a management information systems executive who would lead the post-merger integration critical to future revenue and earnings. Because the due diligence team had the right people, the process was able to contribute significantly to the immediate and long term acquisition success. The due diligence team should be structured to be quick in getting real-world answers to fundamental questions.

2. Ask the right questions.

In many ways, technology due diligence is a detective’s game: the analysts need to look at clues (often from only partial data), and then solve the mystery by defining the business case. Technology should help identifying the ways each facility or function would contribute to (or detract from) the realization of the business benefits, and pinpointing process risks, functions, or the enterprise. Even companies that do a lot of deals are wise to treat each one as a brand new and unique experience.

3. Find weak spots, and then define fixes.

The technology due diligence team needs to address areas of risk, such as the costs and efforts required to harmonize operations, the timetable for fixing problems, and the investment needed for postmerger integration. For example, upgrading an acquired company’s ERP system would be an expensive and resource-consuming project; its costs should be acknowledged.

4. Use facts to negotiate.

The financial decision makers want to know of any issue large enough to stop the deal. But even those problems that are not deal breakers could be used in negotiations. The technology due diligence team needs to be prepared to talk to C-suite executives, bond rating agencies, the investment bankers, and the sellers about issues, potential technology gaps and a course of action with estimated price tag.

5. Bring in the regulators early.

The post-deal organization should inform the FDA or any other regulators of plans to fix recognized problems. Regulators know that a merger or acquisition can create technology confusion and inconsistencies, and they look for that during inspections. Even if there were no problems, it would still be a good idea for the buyer to be proactive in connecting with regulators to help ensure a smooth transition.

Due diligence is a strategy for risk management and return on investment. When done right, it helps assure value creation in a merger or acquisition. Going beyond compliance during due diligence is the key to successful M&A. Even those problems that are not deal breakers could be used in negotiations.

 

About RCA’s Pharmaceutical Consulting Services 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Portfolio Risk Management

Client

Middle-market private equity firm in need of risk management support

Target

Pre-revenue portfolio company

Industry

Pharmaceutical

Business Challenge

Conducting a new product development assessment for a portfolio company

Project Timeline

Pre-launch research & target product profile development – 6 months

Internal implementation of portfolio risk matrix – 3 months

Commercial pipeline analysis – Ongoing

 

Private Equity Challenge

A global private equity firm based in the United States approached RCA to conduct a new product development assessment for a portfolio company. The client eeded industry expertise based on preclinical commercial opportunities in the pipeline and category metrics from the internal product management team. The client also had a need for a voice-of-business research study to be conducted to understand employee attitudes about the key drivers set in place by the commercialization team. Finally, the middle-market PE firm needed data to set a longer-term acquisition strategy based on channel potential and potential acquisition targets that made the most sense for the portfolio.

 

RCA Approach

Qualitative information was used to create a multifactor risk assessment to determine each target product profile and the perception of risk. The assessment included the following key requirements:

  • Business strength factors were ranked by employees who compared key attributes across intended product profiles (e.g. product differentiation, brand equity, etc.)
  • Market attractiveness factors were ranked by employees who compared key attributes across intended product profiles (e.g. market size, competitive forces, etc.)

Voice-of-business research was then conducted to populate the risk assessment. Data was collected through employee responses based on the perspective of product profiles, business strength, and market attractiveness factors.

 

Private Equity Results

Perception mapping and matrix-style results were presented to the client team after all team members completed their voice-of-business survey. Results were weighted across all factors based on team inputs, the importance of strategic factors in relation to other factors, and employee expertise of their specific product category.

RCA discovered many unique data points for consideration by the portfolio company and private equity firm from the risk assessment:

  • The business strength of the preclinical product alternatives were ranked higher than previously anticipated.
  • Market growth rate was perceived to make a greater impact on future sales than current market size.
  • Competitive rivalry in the channel was the greatest risk management factor by the portfolio leadership team. This included a lack of awareness of disruption potential in the channel or the threat of new category competition.
  • Government regulatory environment was consistent across the model due to the compliance-based nature of the life sciences industry. However, power of existing channel partners showed in the data analysis as a differentiator when it came to who could influence the regulatory speed-to-market.

The client team developed talking points for the Board of Directors based on this analysis:

  • Opportunities that were previously considered a secondary priority (e.g. smaller profit margin potential in large sales channels) were to be reassessed based on the sales channel potential.
  • When the cost of capital to develop a preclinical product was held constant across the risk management model, technology and innovation costs quickly escalated.
  • One of the preclinical products achieved a higher score based on the strategic partner in place who could assist commercialization and market sales.
  • Macro-environment change and potential for channel disruption were determined to be decisive gaps for both the private equity firm and portfolio company.

 

Private Equity Takeaways

  • An internal risk management council was established by the Board of Directors to consider how unknown channel disruption may impact their portfolio risk or future new product introductions.
  • Business strength factors signaled the anticipation of success as a pre-approval product portfolio. This was important to the PE firm and portfolio company as a positive indicator even though commercialization lagged behind the existing entrants and competitors.
  • The market growth rate analysis helped the PE firm to recalibrate leadership guidance that pursuing slower CAGR markets larger in size remained just as important as faster growing channels.
  • Portfolio company leadership added additional product management headcount to address the lack of understanding of disruption potential and new category competition.
  • The emerging importance of technology and innovation from the assessment results led to a new project where the portfolio company began examining leveraging manufacturing automation and big data.
  • Recognizing the importance of channel partner strength led the PE firm to reconsider their portfolio bolt-on strategy with existing channel partnerships as a higher priority in targets being considered.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Pharmaceutical Manufacturing

Manufacturing Consultant Services

Whether you are building a new facility or expanding to your existing operations; installing new capital equipment; re-validating existing equipment/utilities or you have been challenged with compliance deficiencies with your manufacturing operations/equipment, facility, or utility, turn to the experts at Regulatory Compliance Associates® Inc. We can develop and tailor the appropriate facility validation program to help.

 

Manufacturing Support

RCA can assist with the entire validation life cycle continuum—starting with the validation strategy / validation master plan through purchase, qualification, and commissioning. We have validation experts that can help and guide you from design qualification, and user requirement definition through factory / site acceptance and through commissioning and qualification.

  • Our service solutions include:
  • User requirement specification (URS)
  • Factory acceptance test (FAT)
  • Site acceptance test (SAT)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • Process qualification (PQ)

 

Expertise in validation of:

  • Equipment
  • Facilities
  • Utilities
  • Computer systems
  • Controls supporting the areas of:
    • Manufacturing
    • Laboratory
    • Utilities
    • Processes
  • Facility validation of existing equipment and operations to stay in compliance
  • Remediation of quality system deficiencies:
    • Manufacturing process
    • Laboratory
    • Equipment
    • Facility

 

Our broad range of Pharmaceutical Strategic consulting services include:

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Outsourcing & Staff Augmentation

In this episode of RCA Radio, host Brandon Miller is joined by Erika Porcelli, CEO of Regulatory Compliance Associates® (RCA), to go over outsourcing leadership roles and how companies use staff augmentation to jump-start their project teams.

Listen in as we talk about what outsourced leadership and staff augmentation are by providing brief background and current trends in the industry. Then move on to talk about the process of augmenting your staff, the benefits, and why having a subject matter expert is critical in these types of projects.

 

RCA Outsourcing  & Staff Augmentation Services

Outsourcing has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the life cycle of the organization. 

All companies experience staffing support issues whether they are transient and short-lived, chronic and unplanned, or intrinsic to your business model. RCA® has pharmaceutical consultants and medical device consultants that can develop a solution to your specific needs; we can help “right-size” your team when and where you need it most.

Project Management

To be successful in the field of manufacturing, you must have a proper project management plan in place. Not only do project management procedures keep your projects on time and on schedule, but they also ensure your devices’ compliance with stringent national and international regulations. RCA can help you develop an effective plan, and we can even lead these tasks so that you can run more projects at one time more efficiently. Our project management capabilities include:

  • On-site Project Leadership or Project Management Support
  • Design and Implementation of a Project Management Office
  • FDA Workshops
  • Project Assessment, Remediation, and Follow-up
  • Advanced Schedule Optimization and Management
  • Development and Implementation of Compliant Methods
    • Risk Management
    • Issues Resolution and Decision Tracking
    • Change Management
    • Performance Measurement and Tracking
  • Tool Selection for Program Portfolio and Resource Management

Staff Augmentation

Many companies need the assistance of a professional with specific skills and expertise when completing a project but might not have the need or resources to hire this expert as a full-time employee. Instead, you can add professionals to your staff for a short- or long-term project through our staffing support capabilities. RCA’s outsourcing solutions can help you manage even your most complex projects with experts trained in areas such as:

  • Quality Assurance
  • Regulatory Affairs
  • Validation
  • Operations
  • Product Development

Consulting Support

Maybe your company is struggling to complete projects on time, or perhaps you often face challenges associated with product compliance. Whatever your situation, our consultants will work with you to ensure your business’ success with consulting support services. By getting to know more about your business and goals, we’ll tailor our approach to best meet your particular needs.

Project-Based Solution Implementation

When you hit a snag in your project’s development, you need to design and develop the best solution to create a timely, quality finished product. Our quality assurance and regulatory affairs consultants can help you define the specific problem, generate ideas for a potential solution, and implement that solution for the utmost success in your project’s completion.

Cost-Effective Staffing Solutions

Manufacturers face the challenging task of creating top-quality products quickly with minimal personnel and growing compliance regulations to adhere to. With these increasing challenges, it’s no wonder so many local startups and Fortune 100 companies alike choose RCA for their outsourcing, staffing support, and project management services.

 

Our goal is to help you get your projects to completion on time and on budget — all while keeping superior quality at the forefront of your every task. And with a team of more than 500 associates and industry experts with an average of 25 years of experience in the life science industries, we have the extensive resources and expertise needed to meet this goal.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.