Regulatory Affairs and Compliance

Our Regulatory, Compliance and Quality Assurance specialists with many years of experience working with Government agencies such as FDA, Health Canada, EMA, CHMP and PMDA will help you to meet any regulatory, compliance and quality assurance requirements for pharmaceutical and nutraceutical operations in accordance to GMP/GLP guidelines.

We can help your new lab facility to acquire GMP Drug Establishment License (DEL) by Health Canada and help your company to prepare for FDA, EMA, PMDA inspections and audits.

Our services include:

  • GMP/GLP licences for FDA and Health Canada facility and product registration
  • Expertise in compliance requirements for GMP, GLP, ICH, USP, EP, JP Guidelines.
  • Preparation and management of ANDA, NDA, DMF, BLA, MAA, IND, CTA submissions to regulatory authorities.
  • Preparation of Standard Operating Procedures as per GMP/GLP guidelines.
  • Create and improve procedures and system to handle controlled drugs, substances, and precursors.
  • Vendor and Lab Audits
  • Quality Control
  • Development of method validation protocols
  • Support all post approval filings
  • XIV Method development, validation and transfer (from protocol approval to final report)
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