Regulatory Services

  • CTDs, ACTDs for Tablets, Capsules, Injections, Metered Dose, Inhalers, Dry Powder Inhalers, Nebulizers, Gels and Ointments and different dosage forms. Also undertake CTDs for Ayurvedic preparations.
  • Analytical Studies, Validation, Elemental Analysis, Stability etc. for finished product and API.
  • Preparation of DMF and also provide vendor DMF required for product registrations.
  • Pack Insert development / SPC development
  • Artwork development for primary/secondary/ tertiary packing materials
  • Can assist Bio equivalence and other Clinical studies (DCGI approved Lab), PSUR Writing, Pharmacovigilance Master File, Immunotoxicity studies etc.