Generic Drug Development

IPHARMED extents support specially pharma generic space on Intellectual Property Rights (IPR), API Development, Generic Formulation Development, Analytical Services, Clinical and Non-Clinical Services.

IPHARMED have highly qualified personnel with in depth knowledge and hands on experience at various levels within the R&D Space. Our team supports clients on research strategies and implementations. We have expertise and experience in chemistry, formulations and analytical techniques. Our team will support to developing intellectual property with development of non-infringing processes/ formulations (505b2) and resolving complex challenges of chemistry.

Let us assist you with :

A) Intellectual Property (IP) Services

  • Validity of Patent or Infringement Analysis
  • Freedom to operate for API and Formulation
  • Patent Writing and Submission
  • Acting as contact personal for litigations

B) Generic Formulation Development Services

  • Pre-formulation
  • Formulation development as per Quality-By-Design (QbD) for following dosage forms
    • Solid oral dosage forms (Tablets and Capsules)
    • Injectables (Lyo & Non-Lyo)
    • Novel Drug Delivery Systems
    • Liquid orals
    • Solutions and Syrups
    • Nutraceuticals and Probiotics
    • Dry Syrups/Powers/Granules/Pellets
  • Technology Transfer
  • Exhibit or Submission batch manufacturing
  • Regulatory Support on documentation

C) Analytical Services

  • Analytical Method Development
  • Analytical Method Validation
  • Impurity Profiling
  • Stability Testing (all zones)
  • Method Qualification
  • Method transfer
  • Elemental impurities testing
  • Technology transfer

D) Clinical and Non-Clinical Services

  • Submission Strategy preparation
  • Identification of Bio Equivalence centre
  • Preparation of BE protocol and Ethics committee approval
  • Regulatory Support on submission documentation and query responses
  • Clinical study
  • Non-Clinical Support
  • Preparation Module 2 summary