Regulatory Consulting

HingeClinica providing regulatory consulting services to Pharmaceutical, Biotechnology, and API manufacture and medical devices.

Regulatory Services:
  • CTD/eCTD Submission
  • Submissions of CTAs
  • Review and compilation of Product Registration dossiers (NDA/MAA/ANDA, IND/CTA, DMF)
  • Life Cycle Management of Annual Reports, Variations, Renewals, Safety Reports
  • 510 K Submissions
  • PMA Submission
  • Preparation and review of T-License, Import/Export dossiers
  • Responses to regulatory authorities or review of deficiency responses.
  • Submissions eCTDs for IND/CTA, NDA/MAA, ANDA
  • Regulatory Agency Liaison
  • DMF compilation for Submission to EU and USFDA in CTD format
  • GMP compliance services for APIs and finished manufacturing facilities