Cognate Bioservices
Cognate Bioservices
, 0 kB
Home Services Regulatory Services
Regulatory Services

Cognate provides regulatory support to companies developing regulated life science products aimed at cell-based and regenerative medicine technologies. Cognate has outstanding expertise to provide regulatory support and services complementing our cGMP compliant Quality Assurance and Quality Control development and manufacturing capabilities. Our goal is to support client efforts in bringing their product to the clinic and commercialization.

Our Comprehensive Package of Regulatory Services:

Preparation of FDA Investigational New Drug (IND) CMC Packages
FDA Pre-IND Meeting Packages
Manufacturing Batch Record Review and Approval
Preparation of GLP Documentation Packages
GMP/GLP Documentation
  • Raw materials specifications
  • Batch records
  • SOPs
  • Quality assurance SOPs
  • Quality control SOPs
  • Assay validation
  • Product lot release testing
Consultation for and Support with FDA Interactions
Vendor Auditing

To print this information:
CB RegServ.pdf

 
, 0 kB