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.
Pharmaceutical Consultant & Pharma 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.
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Client Solutions
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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 pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.
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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.
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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® pharmaceutical industry consultant are 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
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Remediation
Regulatory Compliance Associates® has significant experience and a proven 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, and will assist management with 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, Regulatory Compliance Associates® pharmaceutical industry consultant will prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.
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About RCA
Regulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:
- Life Sciences
- 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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