Services: Outsourced Quality Support-Device

For Medical Device Industry

ISO Compliance Audit

Client

Start up Medical Device company in need of a compliance audit

Business Challenge

Scaling the client’s Regulatory Affairs and Quality Assurance team due to accelerating growth.

About QMS for Medical Devices

The FDA Quality Management System (QS) regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Design controls for new product development are part of a Quality System. Within Design controls is the design history file (DHF) which demonstrates the product design was developed in accordance with the approved design plan and the requirements of the regulations (21 CFR Part 820.30).

Client Challenge

A start up medical device company needed assistance scaling their Regulatory Affairs and Quality Assurance team due to unforeseen growth. Their FDA approved Class II device received exceptional press at multiple industry events and trade shows. Additionally, the team was required to scale quickly as unit sales escalated rapidly within less than a year after product launch.

RCA’s Approach

Regulatory Compliance Associates (RCA) medical device consultants strategized about both short and long term needs of the client. Several members of the client senior leadership team work remotely outside their corporate office. Designing a program around flexibility was important to this group.

Multiple subject matter experts were assigned to provide support for each department of the remote employees. In addition, the client was engaging with a new contract manufacturer (CMO) with greater manufacturing capacity than an existing vendor. A longer-term strategy was put in place to meet growing demand and validate the new CMO’s compliance via an ISO compliance audit.

Manufacturing Support

RCA partnered with the Operations team to perform a supplier audit of the CMO during the initial scope of work. This included RCA medical device consultants reviewing the design control plan, how risk management was incorporated into outputs, a gap analysis of working instructions, and other facets of ISO 13485 compliance support.

Quality Management System

Simultaneously, a second RCA medical device consultant was engaged to partner with the Quality Assurance department. A quality management system (QMS) internal audit was conducted to validate existing standard operating procedures and design history file (DHF) documentation.

Compliance Audit

RCA’s medical device consulting services included performing a compliance audit against both the 21 CFR 820 regulation the product was originally approved for & ISO 13485 global standard. Based on the records in the common technical document, several gaps were identified for remediation. These compliance audit gaps included updates to control plans, process flows, and supplier quality agreements.

Regulatory Documentation

Additionally, establishing a more robust Device Master Record (DMR) to centralize all documents was important to the client. A product family structure was developed in the QMS to help clean legacy data & organize technical documents more efficiently.

Finally, RCA’s MDR consultants also worked with the client team to analyze the existing documentation. A project checklist was created to help with submitting any new files needed for regulatory approval in the EU based on ISO 13485.

Summary

RCA’s medical device consulting experts addressed the gaps that, once remediated, led to the contract manufacturing line being validated as cGMP compliant. The client is now working with an additional RCA compliance consultant to initiate several corrective and preventive action (CAPA) programs to address the updated internal process. Additionally, the CAPA strategy will help provide the client objective examples that corrective action prevents deviations in standard operating procedure.

Finally, the RCA medical device consulting team conducted an operations team training meeting to review regulatory compliance, cGMP manufacturing and compliance audit updates.

 

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. 

Outsourcing Pharmacovigilence

Client

Mid-size in need of Contact Center support for Pharmacovigilance 

Industry

Pharmaceutical and Medical Devices

Business Challenge

Develop a sustainable operational business model for PV, DV, CM, and MI that will meet increasing business demands and escalating regulatory requirements.

Project Timeline

Pharmacovigilance Pre-Implementation Due Diligence – 3 Months

Pharmacovigilance Pilot Site implementation (US Market) – 6 months

Pharmacovigilance Stabilization (US Market) – 6 months

Full Implementation with Staggered regional approach (EU, Asia, Australia New Zealand, South America, Canada) – 4 years

Challenge

A global pharmaceutical and medical device company was having difficulty gaining incremental staffing resources of highly qualified medical professionals to offset local resource shortages to meet the demands of continued business growth and escalating regulatory scrutiny for pharmacovigilance (PV), device vigilance (DV), complaint management (CM), and medical information (MI).

RCA Approach

Identified, developed, and implemented a cost-effective outsourcing model that was scalable and sustainable to meet future changes in staffing and regulatory requirements. The approach used included the following key areas:

  • Leveraged lower cost outsourced staffing resources to handle repetitive, high volume, low complexity transactions to allow the higher cost / higher knowledge internal company resources to focus on high complexity, higher risk, patient impact events or activities.
  • Outsourced call center activities for PV, DV, CM, and MI which included interactions with various stakeholders (medical professionals, sales representatives, and consumers).
  • Internal company information management systems selected and utilized an outsourcing company for data entry, data quality monitoring, and case surveillance.
  • Identified a Business Process Organization Partner (BPOP) that had a large global footprint and could provide outsourced and off-shored call center support to improve efficiencies and reduce operational cost.
  • Outsourced PV, DV, and CM activities included Contact management routing, Intake, Triage, and Logistics management as well as categorization / prioritization of potential high-risk events (Adverse Events, Product Malfunctions) for escalation for potential reporting.
  • Outsourced MI activities included front-line customer support including answering calls, logging cases, and disseminating MI verbal and written communication.
  • Maintained all critical decision making and control to decision making. (report-ability, product safety, regulatory, risk management, etc.)

Results

The business challenge was addressed by utilizing an outsourced and off-shored contact center model. This change in business model resulted in several key improvements and benefits included:

  • Overall cost reduction in Operational Expense of $1.3 MM annually on a functional annual spend of $8.0 MM.
  • Leveraged core competencies of partner for Key Performance Indicators (KPI’s) and functional metrics to achieve process improvements that wer not possible with internal systems and resources. For example; reduction in initial complaint registration process cycle times from 5 days to same day.
  • Freed up internal high cost resources to allow focus on critical work / decisions without being burdened by repetitive / lower value / high volume work.
  • Established a strategic growth partner that was subsequently leveraged when company needed to grow business or had critical initiatives (regulatory actions / requests, recalls, acquisitions).
  • Allowed for consolidation of process work done in decentralized structure to one centralized location that set the foundation for process improvement, process optimization, efficiency, while freeing up regional resources to focus on critical decision making (reporting) and critical relationships (regulators).
  • Allowed adaptation of customer intake approach to evolving customer preference (e-mails versus calling).
  • Allowed for the establishment of quality surveillance of process / personnel on data integrity and content as part of process resources that were not viable using internal resources.
  • Freed up functional leadership to focus on process design robustness, Voice of Customer and Regulatory critical decision making to respond to regulation /expectation changes.
  • Allowed functional organization leadership to become a strength in the eyes of regulators, by focusing on compliance issues, variability of process outcomes, managing regulatory audit outcomes to positive observations while leaving day to day transactions to outsource vendor.
  • Redundancy / Back-up capabilities to take over during crisis (weather, system outage, etc.).

The new outsourced contact center and off-shored model was deemed a company success story that resulted in gaining incremental staffing resources of highly qualified medical professionals, establishing a strategic partner for future growth, substantially reducing overall business operational costs. This project implementation and management process was bench-marked as best in class approach.

 

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. 

 

 

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. 

 

Outsourcing Surveillance

In this episode of RCA Radio, host Erika Porcelli and guest Steve Cox, a Regulatory Compliance Associates (RCA) Senior Consultant, cover the business strategy of outsourcing surveillance in both the medical device and pharmaceutical industries. Not recognized as a business strategy until the late 1980’s, outsourcing is now looked at as a strategic partnership for businesses, growing increasingly in the U.S. with many key considerations at play.

Listen in as we discuss a brief history of business process outsourcing and its impact on the U.S. labor market, functions primary to an outsourcing strategy and the traits they share, the steps and timeline necessary to outsource a workflow, the pros and cons to this strategy, potential change paradigms that could arise, and regulatory considerations.

 

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.