Products Details

  • GMP facility conceptual designing, detailed engineering, QMS documentation, Validation and Calibration services. Documentation, Qualifications and validations Qualifications and validations of facilities, equipment&rsqu

  1. GMP facility conceptual designing, detailed engineering, QMS documentation, Validation and Calibration services.
  2. Documentation, Qualifications and validations
    Qualifications and validations of facilities, equipment’s, instruments, Computer systems validation.
  • Prepare and implement the QMS as per regulatory requirements; train the team and monitoring/ continuous verification of implementation,To develop a system for risk assessment and mitigation plan for entire life cycle of the products.
  • To establish the GMP/ GLP/ ISO systems as per regulatory/ customer requirements based on various markets in quick timelines and cost effective.
  • Execution and documentation for Process validation; cleaning validation; analytical method validations as per regulatory requirements,
  • Qualification documentation (URS/FAT/SAT/DQ/IQ/ OQ/PQ) for Major process equipment and critical systems like water system; HVAC system; Nitrogen system; pure steam generator; compressed air etc.
  • Dossier and Technical   packages   preparations   & support in regulatory queries handling in timely manner, Preparation/ guidance on Dossier preparation,Preparation and management of DMF/ CEP in both hard copy & e-CTD format and expert overview.
  • Audits: Internal audits & assessment audits, Compliance audits,Due diligence audits,Third party audits on behalf of clients in India & abroad,GCP audits,Mock audits before regulatory & major customer audits.
  • Biosimilars & Vaccines: 
  • Formation of Institutional Biosafety Committee, conducting IBSC meeting for newly established companies.
  • Preparation of RCGM documents for getting approval for conducting preclinical toxicology studies, presenting PCT protocol and five batches summary data at RCGM.
  • Identification, audit, preparation of pre clinical toxicology protocol in association with identified CRO and monitoring of studies.
  • Identification, audit, preparation of clinical trials protocol in association with identified CRO and monitoring of studies.
  • Biosimilars / Vaccines  technology transfer
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  • VCARE Consultants has dedicated group of scientific team with technical knowhow for development of process for production of Biosimilar therapeutic proteins in Bacterial, Yeast and mammalian platforms like
  • Recombinant Human Erythropoietin
  • Recombinant Insulin
  • Recombinant Insulin Glargine
  • Recombinant Insulin Lispro
  • Recombinant Aspart
  • Recombinant GCSF
  • Recombinant Interferon’s
  • Recombinant Streptokinase
  •  Recombinant Parathyroid hormone
  • Recombinant Human Epidermal Growth Factor
  • Recombinant Platelet derived growth Factor
  • Technical knowhow for development of process for production of Human vaccines
  • Recombinant Hepatitis Vaccine
  • Tetanus Vaccine
  • Diphtheria Vaccine
  • Pertussis Vaccine
  • Combination vaccines (DPT, DPT-Hep B, DTP-HepB-Hib).
  • Pharmaceutical Formulation development
  • VCARE scientific experienced team of professionals who have an excellent track record in product development right from concept design to product commercialization and supporting customers unleash a greater value. Our formulation development for different dosage forms like
  • Injectables (Vials, Ampoules, Pre filled syringes) 
  • Lyophilized products
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