Services

Regulatory Affairs: We are committed to provide the most efficient, economic, and customer-focused regulatory services. 
Pre and Post Authorisation Regulatory Services include:

  • Consultancy at various stages of drug development.
  • CMC Services - Review of drug substance and drug product data as per regulatory standards.
  • Scientific, Regulatory and Technical Writing.
  • Compilation of regulatory dossier in eCTD and non-eCTD format.
  • Compilation of Drug Master File (DMF) - Open & Restricted Part.
  • Final Submission of dossier to various regulatory agencies.
  • Deficiency Responses to regulatory authority.
  • Compilation and submission of documents for Post-Approval Changes or variations for retaining valid marketing authorisation.
  • Translation of contents of various regulatory documents to and from languages like English, Russian, Japanese, Chinese, French, Portuguese and German & many more etc (Europe & ROW).
  • Regulatory support for Asean Index preparation
  • BTIF preparation for semi regulated markets
  • Preparation of Expert Reports (Quality, Non-Clinical & Clinical)
  • GAP Analysis and support for Extension dossier
  • Pharmacovigilance and RMP related Services.
  • Guidance for Planning, Preparation and Delivery of regulatory submissions throughout the product's life cycle with regional & regulatory perspective.
  • Management of Complex Regulatory submissions.
  • Pre submission Review of Dossiers/CTD and amendments.
  • Guidance for organizing regulatory workshops for upgrading the knowledge of regulatory professionals.
  • Guidance and training to Regulatory Affairs Team.
  • Preparation of Product Development Reports (PDR).
  • Preparation of Toxicology reports (PDE/ADE/NOAEL etc).
  • Preparation of Protocol for Medical devices (Prospective/Retrospective).

Impurity Supply:
We supply high quality analytical impurities and working standards to our Customer on time at best prices. This domain of services includes:

  • Providing high quality certified impurity standard, working standards, API Related Compound in custom pack size.
  • Providing complete set of data HNMR, 13CNMR, Mass, HPLC, IR, TGA, COA along with products.
  • Provide technical and analytical support to clients. 
  • Customise synthesis of product on request.

Medical Writing and Translation:
We offer support to Phamaceutical companies and CROs for medical writing and translation activities. This vertical includes following services.

  • Case Report Forms (CRF) design.
  • Informed Consent Form (ICF) design.
  • Investigator brochure preparation.
  • Translation of ICF and other study related documents.
  • Translation of documents in various global languages.