F&D

Accuprec Research Labs Pvt Ltd. is FDCA approved, OECD-GLP, NABL accredited and ISO 9001:2015 certified CRO. Head Quarter of the CRO is located at Ahmedabad and branch offices at Canada and USA.

Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility and GLP qualified stringent quality control.

Hands on experience in physicochemical characterization, solid state characterization, polymorph screening and salt screening techniques is must. Should have good knowledge on industrial crystallization procedures and drug substance manufacturing process.

Skilled in process validation document preparation and review, with strong knowledge of QMS, qualification documents, regulatory audits, and vendor qualification and audits in a regulated environment.

Lab Exposure, Analytical Method Validation. Review of Specification. Method of Analysis Protocol Handing of 00S and 00T. Investigation and Lab event. Review & Approval of QC Documents. Knowledge of Qualification and Validation related Activities. Audit Trail Review etc 

Perform formulation development activities on differentiated formulations and innovative technologies to achieve Product development. Submission of documents and coordination with liaison personnel for procuring required licenses for carrying out the development work. M.Pharm or Ph.D. in Pharmacy with minimum industrial experience

Plan, implement and evaluate experiments for establishing of composition, manufacturing procedures and packaging via support of def. evaluation experiments taking product stability, bioequivalence and possible production site into consideration.

Conduct literature survey and compile the scientific findings for allocated projects. Plan and perform the Pre-formulation studies, and innovator product characterization.

Knowledge of regulatory guidelines applicable to formulation development. Must have handled ER, MR, Pellets drug products for US and EU market.