Experience

Søren Bogø was until recently Director, QA & Regulatory Affairs for HemaSure Denmark A/S, Denmark. Before that he was Director of Quality Assurance for the Biopharmaceuticals Division of NOVO NORDISK A/S, Denmark and later Director of QA, Growth Hormone and Biologics for the same company. In all these responsibilities he held the position as qualified person in accordance with EC Directive 75/319.

He has over twentyfive years of practical experience in all aspects of the manufacture and quality assurance of sterile pharmaceuticals (drugs and biologics) and has extensive experience with worldwide regulatory requirements and cGMP compliance issues. He is a member of the Parenteral Drug Association and the International Society of Pharmaceutical Engineers.

Taken alltogether SB´ extensive experience ensures clients that all aspects of their compliance issues are handled professionally. His work as a consultative partner with clients, applying resources, techniques and approaches that are based on years of pharmaceutical experience, includes quality assurance, consultation and training, design and implementation of documentation systems, validation services, internal and external audits, and preparation for inspections.

Recent assignments

Danish In-vitro Diagnostics developper/manufaturer: Validation Plans, cGMP.
International Pharmaceutical Company, manufacturing in Sweden: Cleaning Validation Master Plan.
Internat. Pharmaceutical Company, Copenhagen: Validation Projects, Regulatory and QA related assistance.
Supplier for medical device and pharmaceutical industry: QA & cGMP related consulting, Quality Manual (ISO9000).
Danish Pharmaceutical Company: QA consulting, US-FDA compliance issues, vendor audits.
Supplier of diagnostics: QA/ISO consulting.

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