BioPharm Process Associates biopharmaceutical manufacturing, bioprocess development and due diligence consulting
biopharmaceutical quality and regulatory services

root cause analyses and corrective actions

complete quality systems

Quality/Regulatory Services

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.

Some of the services we can provide for you include:

  • Design and implement quality systems, including quality policies, SOPs and document control systems
  • Set up out of specification procedures, including root cause analyses and corrective actions
  • Streamline master production record design and set-up
  • Audit executed batch production records
  • Write the chemistry, manufacturing and controls (CMC) section for your regulatory filings (IND, BLA, etc.)
  • Define an appropriate process validation plan, including a validation master plan and the production of qualification lots
  • Establish intermediate, bulk and final product release testing and specifications
  • Perform cGMP and GLP audits
  • Implement effective and time-efficient cGMP and GLP training
  • Prepare for on-site inspections by US or European regulatory authorities
  • Coordinate responses to regulatory agency questions about filings, observations during inspections or warning letters

BioPharm Process Associates
(803)-548-9979 Telephone

Quality/Regulatory Services