Pharmaceutical Validation Services (P.V.S) is a Canadian consultancy firm for Pharmaceutical and Biopharmaceutical industries involved in the manufacturing of Active Pharmaceutical Ingredients (APIs) and Finished Products for clinical and commercial uses.

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P.V.S. experts provide you with extensive experience and professional services to help you to meet facility design compliance and to ensure the safety, purity and efficacy of your products and conformity with specifications and regulatory requirements.

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Our experts have a large knowledge in Canadian, American and European pharmaceutical and biotechnology standards and requirements such as: GMP, GLP, GCP, ICH, FDA CFR 21 Parts 11, 58, CE, OECD, CBER, ICH, IES, ISPE & AAMI/ANSI/ISO guidelines.

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P.V.S. is covering API and Finished Product manufacturing for Drugs and Biological products (recombinant proteins, monoclonal antibodies) for the majority of product forms (liquid and solid dosage forms, ointments and creams). Our experts help you in the planning and execution of the different activities related to product manufacturing and release, e.g. Quality Assurance, Quality Control, Process Validation, Regulatory Audits, Vendor Inspection and Qualification, Stability Studies, Manufacturing and Laboratory Equipment Validation and Qualification, Gap and CAPA analysis and management, Change Control Systems and Customer Complaints Investigations.

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Key areas of expertise include: