Services

International Activities
Diligence
Start-up Services
Pre-Market Services
Manufacturing/Post-Market
Special Areas of Expertise

Special Areas of Regulatory Expertise

Drugs and Combination Products Regulatory Consulting

  • Submission and maintenance of Drug Master Files (DMFs)
  • Evaluation of drug/device and biologic/device interactions, including extractables and leachables studies in cooperation with internationally recognized laboratories
  • Requests for Designation (RFDs)

Pharmaceutical Packaging Regulatory Consulting

  • US FDA: Type III DMF preparation and submission, including amendments, LoAs, annual reports
  • Health Canada: Type II DMF preparation and submission, including amendments, LoAs, biennial updates
  • US Agent and HC Correspondent services

Electronic Submissions in eCTD format

Crisis Management

  • FDA 483 Responses
  • Product Recalls and Remedial Actions; Field Safety Corrective Actions and Notices

Regulatory and Quality System Training

  • Quality System Implementation and Procedures
  • Best Practices for Design Control, Risk Management, Biocompatibility to meet FDA and ISO 10993 requirements, and Clinical Evaluation Reports

Biocompatability Consulting

  • Implementation of biological safety (biocompatibility) procedures and establishment of biological safety department
  • Preparation of Health-based Risk Assessments for Polymers, including additives and colorants (pigments and dyes)

Medical Device Start-up Consulting and Services

  • Coordination and integration of regulatory tasks into product development activities