Comprehensive Regulatory Services to Meet Your Needs

Our regulatory services support the development, registration, and maintenance of
pharmaceutical and medical device products across global markets. We provide tailored solutions across a range of dosage forms and regulatory requirements.

Regulatory compliance support

  • Expert preparation and management of regulatory applications and submissions for IND, NDA, ANDA and BLA
  • Hybrid applications and iterature based submissions
  • Health authority correspondence management
  • Ad-hoc Regulatory Consulting
  • Comprehensive GMP & GLP audits to ensure adherence to FDA, EMA, TGA and other regulatory guidelines
  • GMP and GLP gap analysis

Dossier preparation

  • eCTD Preparation and submissions
  • Dossier gap analysis
  • Post approval life cycle management

Licenses and Approvals

  • Import and export license applications and approvals for medical research
  • CTX/CTIL, BENOC for generics and biologics
  • EC approval
  • CDSCO, NPRA, ANVISA, GCC, NABL, ISO Accrediations

Markets Covered

USA , Canada, EU ,UK, AUS, GCC, Swiss, Latin America, Asia pacific

Product Types

  • Generics-Rx and OTC-Solid orals, Oral liquids
  • Complex generics, biologics, injectables
  • Topicals, Opthalmics
  • Medical device products