Our expert team delivers specialized GxP compliance and regulatory support to global clients across the Pharmaceutical, Biotech, Nutraceutical, Veterinary, and Medical Device industries. With proven experience in QA/QC, Microbiology, API, OSD, Parenteral, Topical formulations, and more, we’ve successfully completed projects worldwide—collaborating with both established companies and emerging innovators.

Our Core Services Include:

Regulatory Services

  • Dossier Due Diligence
  • Marketing Authorization (MA) Filing & Lifecycle Maintenance
  • Contract QP / RP / RPi Services

GxP Compliance

  • EU GMP / US FDA Audits
  • Mock Regulatory Inspections
  • GxP Gap Assessments
  • GxP Remediation
  • GxP Training Programs

Medical Devices

  • Regulatory Consulting, CE marking, EAR, UKRP, MDR compliance, and technical documentation