Process Excellence for Successful Biopharmaceuticals

Quality & Regulatory

Quality & Regulatory Services

BioPharm Process Associates can create a global CMC-regulatory strategy, identifying the essential regulatory requirements as well as outlining all product quality and process performance parameters within your specified timelines and budget.

We have first-hand experience with the necessary quality and regulatory requirements for your products, including both the set-up and operation of complete quality systems. We have coordinated and written components of numerous regulatory filings in both the US and Europe. We have validated pharmaceutical facilities, utility systems, process equipment and manufacturing processes, so we can save you time and prevent having to repeat critical regulatory steps.

Drawing on our extensive and comprehensive quality and regulatory experience we can:

  • Write global regulatory submissions, including US INDs, NDAs, BLAs, and their foreign equivalents, using eCTD templates
  • Identify critical quality attributes (CQAs) and critical process parameters (CPPs) to ensure quality by design in the cGMP processes used to manufacture your product
  • Design and implement phase-appropriate quality systems, including quality policies, SOPs and document control systems
  • Define an appropriate process validation plan, including a validation master plan and the production of qualification lots
  • Plan and prepare for on-site inspections by regulatory authorities
  • Perform cGMP and cGLP audits of your facilities or your CDMO, testing laboratories and raw material suppliers to ensure appropriate regulatory compliance
  • Perform pre-approval inspection (PAI) or for cause audits
  • Write, review, or edit development reports detailing the process development, validation, manufacture or process and product comparability for inclusion in global regulatory filings
  • Coordinate responses to regulatory agency questions about filings, observations during inspections or warning letters
  • Plan and attend CMC regulatory meetings with US and European regulators