Regulatory

Regulatory information

  • An integrated Quality Management System (QMS), regularly re-evaluated by recognized authorities, ensures that our products comply with all appropriate standards.
  • Analytical certificates are issued with compliance to the principal pharmacopoeia monographs: USP/NF,BP, Ph. Eur, JP. & IP.
  • A professional audit in-house group provides an inclusive service for all our pharmaceutical ingredients making compliance to regulatory bodies.
  • Crest cellulose will also have Certificate of suitability (CEP) from the European Directorate for the Quality of Medicines (EDQM) for all its excipients.
  • Crest will also have WHO, GMP and Drug License registration.
  • Crest will endeavor to adhere to all regulatory norms that are required for all pharmacopeia standards & Food Regulations.
  • Crest will be certified by ISO 9001,14001, 18001 & 22000 Certifications
  • Crest will be certified by Kosher Certification.

At Crest, excellent regulatory and quality support is provided. We help our customers Minimize risks by offering:

  • Advice on regulatory requirements for target markets.
  • Assurance that excipient products meet appropriate regional regulatory requirements.

This is achieved by:

  • Maintenance of regulatory reference databases.
  • Preparation and maintenance of licenses, and Drug Master Files (DMF) to ensure appropriate regulatory status for intended use in target markets.