Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management. This involves maintaining high standards, and meeting stringent requirements of quality, safety, and accurate labeling.
DISCOVER MOREOur Comprehensive Regulatory Approach to Post-Approval Lifecycle Management
Effective post approval lifecycle management is critical to sustaining high standards of quality, safety, and accurate labeling. Our Regulatory Life Cycle Management Services are designed to manage any administrative, labeling, or quality changes that may impact your production process and regulatory compliance. This structured approach underpins our commitment to robust process of lifecycle management.
Once marketing authorization (MA) is granted, any subsequent changes in production, labeling, or processes require supplemental filings. By adhering to frameworks such as the Q12 ICH guideline and EMA’s EC No. 1085/2003, our strategy ensures seamless drug life cycle management and supports continuous pharmaceutical and biotechnology product lifecycle management for your products.
Our Post-Approval Life Cycle Management Process
At DDReg, our highly skilled regulatory and post-approval specialists deliver top-tier life cycle management pharma solutions. We manage post approval changes that include Type 1A, 1B, II variations as defined by EU regulations, along with CBE, CBE 30, and PAS submissions required by the US FDA. Our process is designed to anticipate regulatory requirements and streamline supplemental filings for any modifications.
We meticulously handle updates such as labeling change notifications, artwork changes, manufacturing process modifications, MAH transfers, CEP updates, and monograph revisions to maintain compliance with Pharmacopoeia standards. Proactive management is essential for sustaining market value and ensuring your product’s ongoing success.
Our Post-Approval Life Cycle Management Expertise
- Managing variations and post-approval change notifications
- Labeling Change Notifications/Approvals and Artwork Changes
- Manufacturing Process Modifications
- Marketing Authorization Holder (MAH) Transfers
- Certification of Suitability (CEP) Updates/New CEP Applications
- Monograph Updates & Compliance with Pharmacopoeia Standards
- Shelf-life Extension or Reduction
Ready to maximize your product value with expert post approval lifecycle management?