DPM has the extensive QA experience to play a key role in developing quality and compliance strategy for emerging and established companies. We can also provide supplemental resources for ongoing quality operations for both clinical and commercial operations. This includes activities such as review of batch manufacturing records, change management, and product disposition.

DPM can perform GMP audits of contract manufacturers, contract laboratories, and suppliers. We have extensive experience with pre-approval inspections from the US and EU. An area of special interest is the development and implementation of phase appropriate quality systems to bring a risk-based philosophy to the quality systems as outlined in ICH Guideline Quality Risk Management Q9.


Quality Management

  • QA Management and Strategy
  • QA System Evaluation and Development
  • Phase Appropriate Quality Systems Development
  • QA involvement in Project Teams

QA Operations

  • Batch Manufacturing Record Review
  • Clinical and Commercial Product Disposition
  • CAPA and Exception Reporting
  • Change Management
  • GMP Training

QA Audits

  • GMP Auditing (internal and external)
  • Planning and Preparations for PAI inspections
  • Qualification of Contract Manufacturers, Laboratories and Suppliers
  • FDA and International Regulatory Submissions (510k, PMA, etc.)
  • Medical Device Class II and III

REGULATORY AFFAIRS

 

  • Manufacturing SOP writing
  • Validation documentation support
  • Batch Record authoring and editing

TECHNICAL WRITING