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.