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Lifecycle Management
Maximize your product’s success post-approval with expert lifecycle management
We ensure seamless compliance, manage regulatory changes, and mitigate risks—helping you maintain market access and unlock new opportunities for growth.
Comprehensive Post-approval Services
- CMC: Accurate assessment and categorization of CMC changes, with the preparation of critical modules like 3 and 2.3.
- Nonclinical Support: Managing post-approval commitments to ensure continued compliance with regulatory expectations.
- Clinical Oversight: Facilitating the extension of product indications and overseeing necessary labeling changes.
- Market Access: Strategic guidance to maintain and expand product availability.
- Post-Market Pharmacovigilance (PV): Ongoing safety monitoring and reporting to meet regulatory requirements.
- eDRLS (Electronic Drug Registration and Listing System): Managing Labeler Code Requests, Establishment Registrations, Drug Listings, and reporting under the CARES Act.
- Variation and Supplements Strategy: Handling product variations, supplements, and controlled correspondence to maintain compliance with evolving regulations.
Why partner with VCLS?
- Proactive Compliance & Risk Mitigation: We stay ahead of evolving regulations, ensuring your product remains compliant post-approval while minimizing risks that could impact market access.
- Global Expertise & Local Insight: With in-depth knowledge of global regulatory frameworks and local market nuances, we help you navigate complex requirements and optimize your product’s performance worldwide.
- Tailored, Long-Term Support: Our collaborative approach delivers customized solutions that align with your business goals, offering ongoing strategic guidance to unlock new opportunities and drive sustained growth.
FAQs
Who is required to register and list with the FDA?
The owner or operator of an establishment entering into the manufacture, preparation, propagation, compounding, or processing (which includes, among other things, repackaging and relabeling) of a drug or drugs must register the establishment with FDA within 5 days after beginning the operation.
This includes all contract manufacturers involved in any step of the manufacturing supply chain.
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How is a change to an approved NDA/BLA/ANDA categorized?
Changes are categorized based on a series of evaluations regarding the change.
If multiple changes are related, the reporting category will be the most stringent of the cumulative changes. It is important to stress that the categorization is based on the change and not the outcome of the change.
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Related Glossary
United States Agent
Electronic Drug Registration and Listing System (eDRLS)
Annual Report
Post-Approval Change Management Protocol (PACMP)
Supplement
Questions? Get the answers by our expert team
No two product developments are the same, talk to our experts about your development challenges and we will provide your actional recommendations.