(O-408) 733-1199
(F-408) 730-5959
 info@antrix.com

Regulatory Affairs and Quality Assurance
Consulting Services

  1. Quality Management System (QMS) Development and Deployment

  2. Quality and Regulatory Training

  3. Site Quality Plan, Site Regulatory Plan, Validation Master Plan and ISO 13485 Certification

  4. Document Control and Records Management

  5. Nonconforming Material Report (NCMR), Deviations and Corrective Action, Preventive Action (CAPA)

  6. Internal, External and Due Diligence Audits on Acquisition Companies

  7. Risk Management Plan, Analysis and Report as per ISO 14971, Hazards Analysis, FMEA, and FTA

  8. Regulatory Plan, Strategy, Development and Execution for Medicinal Products, Drugs, Medical Devices and Combinational Products

  9. Regulatory Electronic Submission Preparation and Filing for Drugs, Medical Devices and Combination Products based on eCTD and STED Standards

  10. Title 21 CFR Part 11 Assessment and Compliance

  11. Validation of Computer System Used in Production and/or Quality Systems

  12. Verification and Validation of Medical Device and Research Use Only (RUO) Products

  13. Manufacturing Process Validation

  14. Medical Device, Drugs Labeling and Advertising

  15. Complaint Handling, Recalls and Medical Device Reporting

  16. Response to FDA Form 483 Observations and Warning Letter