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