case study

Product Launch Plan

A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team, with the objective to reduce the product release timeframe. However, they lacked internal experience to embark upon this initiative.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Product Launch Plan

Background

product launchA generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team. The objective was to increase efficiency and reduce the product launch timeframe. However, they lacked new product launch experience to embark upon this release plan initiative.

 

Solution

The pharmaceutical company looked to the Regulatory Compliance Associates® Inc. pharmaceutical consultants to improve efficiencies in the manufacturing, batch approval and release plan to the distribution system.

The RCA experts used process mapping to identify redundancies, inefficiencies, and other opportunities inside the product launch checklist. In partnership with the company process owners, new processes were systematically developed and implemented. Employee departments involved included the Quality team as well as Manufacturing operations.

 

Result

The RCA experts reduced the 30 day process down to four days. This process improvement reduced the release plan time necessary for the company to retain costly inventory, allowing them to reduce investment by improving speed and reliability of product delivery to customers. This reduction in product release cycle time across multiple plants impacted the company’s cash flow, which internal experts estimated to be $50 million.*

By moving work-in-progress product more quickly into finished goods inventory, the company lowered carrying costs and floor space cost. By reducing the product release cycle time, the plant experienced less issues with back orders and short-dating. Additionally, for some export markets, the plant was able to ship product less expensively via boat instead of air.

*Cash Flow Improvement = product unit cost X # units produced/day X # days release cycle time improvement

 

About RCA’s Pharmaceutical Consultants

Regulatory Compliance Associates® Inc.’s background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory, compliance, quality assurance, and remediation challenges, in addition to their strategic consulting needs. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and 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, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our 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 pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.

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

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

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

 

Remediation 

Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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 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

 

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

Background

product launchA generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team. The objective was to increase efficiency and reduce the product launch timeframe. However, they lacked new product launch experience to embark upon this release plan initiative.

 

Solution

The pharmaceutical company looked to the Regulatory Compliance Associates® Inc. pharmaceutical consultants to improve efficiencies in the manufacturing, batch approval and release plan to the distribution system.

The RCA experts used process mapping to identify redundancies, inefficiencies, and other opportunities inside the product launch checklist. In partnership with the company process owners, new processes were systematically developed and implemented. Employee departments involved included the Quality team as well as Manufacturing operations.

 

Result

The RCA experts reduced the 30 day process down to four days. This process improvement reduced the release plan time necessary for the company to retain costly inventory, allowing them to reduce investment by improving speed and reliability of product delivery to customers. This reduction in product release cycle time across multiple plants impacted the company’s cash flow, which internal experts estimated to be $50 million.*

By moving work-in-progress product more quickly into finished goods inventory, the company lowered carrying costs and floor space cost. By reducing the product release cycle time, the plant experienced less issues with back orders and short-dating. Additionally, for some export markets, the plant was able to ship product less expensively via boat instead of air.

*Cash Flow Improvement = product unit cost X # units produced/day X # days release cycle time improvement

 

About RCA’s Pharmaceutical Consultants

Regulatory Compliance Associates® Inc.’s background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory, compliance, quality assurance, and remediation challenges, in addition to their strategic consulting needs. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and 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, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our 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 pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.

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

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

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

 

Remediation 

Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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 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

 

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

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