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End-to-end pharma support

Eight ways we support your pipeline

From licensing and formulation through to IP strategy and business development — explore each service below.

  • Test Licence for Pharmaceuticals on Form 29.
  • Import Licence for API.
  • Import Licence for Innovator product.

  • Formulation development for US/EU/ROW market.
  • Development and Technology transfer.
  • Pilot BE study.

  • Connection with CRO & CMO’s for development and execution of all kinds of dosage forms like Tablets, Softgel, Hard gel Capsules, Topicals, Injectables, Oral films, Oncology and Liquids. Exhibit batches and filing support for US / EU / Canada / Australia / ROW market.

  • Strong connection with CRO centers for conducting BE and clinical studies for US/EU market.
  • Identification of CRO already expert in a similar product to circumvent BE failures.

  • Quality/cGMP Audits: Pre-Agency Assessment Audits, Mock Audits, Vendor Qualification Audits.
  • CMC Dossier Writing: ANDA, NDA, BLA, DMF, VMF, IND and 505(b)(2) and MAA filing for global markets.
  • Labeling: Preparation of Package Insert / SmPC & Artwork.
  • US Regulatory Agent: Controlled Correspondence and USFDA Communication.
  • Other Regulatory Services: PDE and OEL.

  • Identification of generic product for US/EU/Canada/Australia/ROW Market.
  • Identification of first-to-file product.
  • Identification of para IV product.
  • Identification of complex generic.
  • Identification of niche opportunities.
  • Identification of product as per therapeutic category.
  • Identification of product as per dosage form.
  • Identification of 505(b)(2) opportunities for US Market.
  • Identification of innovative product for worldwide market.
  • 505(b)(2) / Innovative product recommendation.

  • IP due diligence of dossier.
  • Freedom to operate opinion.
  • Non-infringement opinion.
  • Designing IP strategy for non-infringing product.
  • IP due diligence of invention/patent for out-licensing.
  • Patentability opinion on invention.
  • Patent filing and drafting.
  • Patent prosecution – filing request of examination / replying to office actions / hearing / annuity payments.
  • Patent invalidity searches.
  • Key literature search.
  • Patent landscape report.
  • Other scientific trouble shooting.

  • Out-licensing of product.
  • In-licensing of product.
  • Development projects.
  • Co-development project.
  • CMO opportunities.
  • IMS Data.