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Services We Offer

DOSSIER LICENSING & SUPPLY OF THE PRODUCT

Dossier registration in Regulated market like, European countries / UK MHRA / USFDA / CANADA / South Africa (MCC) /TGA- AUSTRALIA Dossier registration in Rest of world like, Latin America, South East Aasen, African countries, GCC, CIS etc On dossier approval, manufacture & supply commercial batches.

SUPPLY OF CHEMICALS & ACTIVE PHARMACEUTICALS

Amegh has tie up with renowned Chemicals & Active Pharmaceuticals vendors for customers satisfactions with high quality& affordable Prices.

CONTRACT MANUFACTURING

Site variation or Tech transfer projects.
Responsible for validation batches & generation of stability data.
Contact manufacturing and supply the product at reasonable rates.

CONTRACT R&D AND PRODUCT DEVELOPMENT

To develop formulation as per customer needs.
Perform & guidance about BE studies.
Develop and compile registration dossier ACTD, CTD & eCTD formats.

PATENT CHALLENGE OPPORTUNITIES

We develop patent Non-infringing formulations for landscaping (Patents) by our regulatory & IPR team.

Regulatory Affairs

  • Well experienced regulatory affairs team with more than 15 years of experience in regulated market.
  • Regulatory affairs is well versed with regulatory guideline of USFDA/UKMHRA/EMEA/TGA/HEALTH CANADA/MCC/GCC/CIS/South East Aasen.
  • Regulatory affairs is adapt in compiling of ACTD, CTD & eCTD dossiers.
  • RA is adept at lesioning with various regulatory authorities and prompt in query handling for obtaining timely product approval / Marketing Authorization (MA’s)

Intellectual Property Management Cell (IPMC)

  • Amegh IPMC houses is a well experienced & skilled team with technical knowledge in Pharmaceutical Sciences.
  • Amegh IPMC is a skilled in patentability analysis, filling national & international patent applications.
  • IPMC is an indispensable support for elucidation of R&D product pipeline and product filing strategies.