Biopharmaceutical Services in Wanwadi, Pune

Afra pharma consultant has collaboration with an iso 90001 certified worldwide pharma consulting and engineering company with more than 1600 people at more than 20 locations worldwide and handles up-gradation projects to turn key projects in pharmaceuticals, biopharmaceuticals, medical devices, vaccines and industrial biotech and api. we offer professional services to clients’ specific requirements and take pride in providing current top quality state of the art engineering. we undertake comprehensive management of all project activities, right from conception through completion of construction and commissioning, including continuous monitoring, thereafter to achieve the projected savings in time and money to add value to our services for the benefit of our clients. we also assist in the up gradation of plants in accordance with the latest industry standards. we are proud to state that the facilities we have successfully commissioned, in india and abroad, have complied with the demanding standards and requirements of international companies like conforming to cgmp requirements and us fda & uk mca guidelines. pre audit: afra pharma consultant assists clients to prepare for an imminent regulatory inspection by carrying out one or more mock regulatory audits in advance of the real thing. our consultants will visit the your facility and carry out an inspection in the style of the relevant regulatory body (fda, mhra, ema, saudi fda, gcc etc.) after which we provide: an in-depth, impartial and professional assessment of their current state of compliance a detailed, prioritized action plan for the rectification of areas of non-compliance and vulnerability staff coaching in the sorts of questions which are likely to be asked during the inspection and how best to answer them sound, practical support and advice in the run-up to the real inspection.

We offer- • Quality System Certification & Documentation: Preparation, Maintenance, guidance for FDA, WHO-GMP, USFDA, MHRA, EDQM • Validation & Qualification: Area, Process equipment, process, water system, HVAC, Cleaning, Personnel, Analytical services, Lab instruments • Internal Audits & Customer Audits • cGMP audits • Vendor audits & Vendor qualification • Laboratory set up, up-gradation to FDA, WHO- GMP, USFDA, MHRA, EDQM, GLP & GMP Standards. • Recruitment and Training • Specifications: Raw material, Packing material, In Process materials & Finished products specification • Ayurvedic formulation development & documentation as per FDA requirements • ISO 9001:2000 & PS 9001:2000, Regulatory assignments.

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