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
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
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)
