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Part of US based
Semler Group of Companies,
in business since 1946

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Phase I, II & III

Semler Research Center (SRC) has in-depth expertise in developing formulations of new chemical entities for phase I, II and III  for US, European, Indian and other regulatory submissions.

We have the capabilities for Active Pharmaceutical Ingredient (API) characterization & salt specifications, manufacturing of feasibility batches, Clinical Trial Material (CTM) manufacturing with partners and early phase stability studies in High Density Poly Ethylene (HDPE) bottles and in blister packs.

We provide complete analytical validation as per ICH guidelines, develop discriminating dissolution media and support scale-up, process optimization & validation and the manufacture of exhibit batches. We complete the loop by providing the final product specification for Quality Control (QC) and a well-defined process for the design and review of Chemistry, Manufacturing and Controls (CMC).

Phase I

  • Small scale formulation for FIH/PoC study
  • Tentative specifications for API
  • Manufacturing of feasibility batches
  • CTM manufacturing and packing as per GMP with strategic partners
  • Early phase stability studies in HDPE bottles and various blister packs

Phase II & III

  • Formulation development finalizing the trade dress of the formulation
  • Complete analytical validation as per International Conference on Harmonization (ICH) guidelines
  • Development of discriminating dissolution media
  • Scale-up, process optimization & validation and manufacture of exhibit batches
  • Final product specification for QC
  • CMC support
 

About This Service

SRC offers top-notch scientific expertise across dosage forms and modes of administration. Our scientists have several decades of experience in developing products for US, EU, India, Brazilian, Turkish, South African & other markets across diverse therapeutic areas.