Provides customized laboratory and clinical manufacture services to pharmaceutical and allied industries

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CLINICAL MANUFACTURE

  • Upgraded facility including certified clean rooms for aseptic processing and sterility testing, supported by fully equipped analytical and microbiology laboratories.
  • Extensive experience in the clinical manufacture (phase-1 and 2) of a variety of dosage forms including parenterals, intra-nasals and topicals.
  • Fully equipped and experienced in handling of cytotoxic drugs.
  • Experienced in developing customized batch records or using the client-provided batch records.
  • Develop/optimize formulation & manufacturing processes.
  • Develop/validate sterilization cycles and plan & implement manufacturing support studies.
  • Plan & implement in-process testing; finished product release testing; and stability studies (ICH).
  • Cleaning procedures and cleaning validation studies.
  • Develop labeling and packaging for the manufactured batches.
  • Develop and assemble CMC regulatory submissions.

 

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