Compliance & Regulatory Services

C-CREST offers comprehensive regulatory affairs and quality systems support to expedite product approvals or post-approval maintenance. We have resource capabilities to become your primary regulatory/quality affairs service provider.

Our services include, but are not limited to, the following:

Regulatory submissions, applications, approvals and support

  • New drug submission (NDA/NDS)
  • Generic drug submission (ANDA/ANDS)
  • Product labelling and marketing documentation reviews and submissions
  • Drug identification submissions (DIN and NDC)
  • Drug master file (DMF)

Quality systems and quality assurance

  • GMP audit, assessments and training
  • Quality system development and inspection readiness
  • Documentation development and management
  • Vendor qualification
  • Master validation plan
  • Quality assurance and product release for Canada
  • Corrective and preventive action programs

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