Post-approval supplements US FDA - Techsol Life Sciences

Life Cycle Management

Post-approval supplements US FDA

As part of a strategic approach to lifecycle management, we help pharmaceutical manufacturers navigate post-marketing changes efficiently and compliantly.

Post-Approval Supplements

At Techsol, we specialize in providing comprehensive regulatory support for the preparation and submission of Post-Approval Supplements (PAS) to ensure ongoing compliance with FDA requirements. As part of a strategic approach to lifecycle management, we help pharmaceutical manufacturers navigate post-marketing changes efficiently and compliantly.

Our regulatory team manages all supplement types including CBE-0, CBE-30, and Prior Approval Supplements (PAS) supporting changes related to manufacturing processes, formulation, labeling, and packaging. We ensure proper classification of each change, complete and accurate dossier preparation, and timely submission to facilitate FDA review, reduce approval timelines, and maintain uninterrupted product availability.

Our Services Includes:

Techsol supports all categories of FDA post-approval supplements, with precision and compliance at the core of our services:

CBE-0 (Changes Being Effected – Immediate Implementation): Submissions for changes that may be implemented immediately upon FDA receipt. Our team prepares and submits supporting documentation concurrently to meet regulatory expectations.
CBE-30 (Changes Being Effected in 30 Days): For moderate changes, Techsol ensures submission of all required data 30 days prior to implementation, enabling clients to proceed with confidence upon FDA clearance.
PAS (Prior Approval Supplements): For significant changes requiring FDA review and approval before implementation, our regulatory experts craft robust submission packages to minimize review cycles and mitigate risk of delays.

Our Expertise

At Techsol, we bring deep regulatory expertise and a proactive approach to managing post-approval changes across global markets. Here’s why leading pharmaceutical companies trust us:

End-to-End Support: From strategy development to submission and agency follow-up, we manage the complete lifecycle of post-approval changes
Global Regulatory Expertise: Proficient in FDA, EMA, and other major regulatory authorities' requirements for supplements, variations, and amendments
Accurate Change Classification: We perform impact assessments and determine the correct supplement type, reducing the likelihood of FDA rejections or resubmissions
Submission Excellence: Our team delivers fully compliant, submission-ready dossiers (eCTD/NeeS), ensuring timely and successful filings