Category: Blog

The USA Food and Drug Administration (FDA) recently provided updated regulatory guidance for Product Lifecycle Management in the pharmaceutical industry. The guidance helps pharmaceutical companies and manufacturers better understand the administration of post-approval chemistry, manufacturing, and controls changes.

Lifecycle Management

The guidance provides new insights into lifecycle management concepts for both new and existing pharmaceutical products, including chemical and biologics. The FDA regulatory team looked to synchronize its updated guidance more closely to ICH guidelines used with other global regulatory agencies.

The benefit realized by pharmaceutical companies would be options for reducing duplicate clinical studies and increasing the standardization of safety information reporting. By revising facets of FDA marketing application submissions as well, the Agency appears to be taking a more holistic approach to improving drug development quality and pharmaceutical manufacturing strategy.

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Manufacturing Process

Changes include language revisions to surrounding regional legal frameworks, an expanded clarification of critical process parameters, and identifying established conditions for manufacturing processes. One important revision for regulatory affairs employees is the new recommended content of the product lifecycle management document and its location within the technical file. Clarity revisions were also made to further expand on the use of available tools described in the guideline for master files.

Regulatory Submission

The new FDA guidance also expanded its language on post-approval chemistry, manufacturing, and controls changes. With additional tools and principles intended to improve the industry’s management of post-approval changes, FDA leadership is hoping to increase transparency between both industry employees and regulatory authorities.

The benefit to pharmaceutical companies should be a deeper understanding of how product and process knowledge will contribute in the real world to post-approval changes that require a regulatory submission. By defining the level of reporting categories, industry experts should experience a deeper understanding of risk compared to product quality.

Quality Management System

The new tools and principles are designed to improve data input into a company’s quality system. The goal is to enhance the industry’s ability to manage many chemistry, manufacturing, and controls changes that have a lower priority needed of regulatory oversight.

At the same time, many at the FDA are hopeful the tools and principles could result in fewer Marketing Authorization Application submissions that increase the associated regulatory burden. The guidance should increase both operational efficiency and regulatory flexibility when implemented with the proper regulatory framework and applied with widely accepted risk management principles in the pharmaceutical industry.

About RCA Pharmaceutical 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, 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

Regulatory Compliance Associates^® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

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 more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

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