Regulatory Affairs Consultancy
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Preparation of non-
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Guidance on pre-
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Design, monitoring, reporting and interpretation of preclinical & non-
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Preparation of expert reviews of materials, their chemical safety & toxicology for medical applications
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Preparation of responses to regulatory authorities on safety, biocompatibility & toxicology questions
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Guidance on regulatory developments & advice on proposed use of animal or human tissues or derivatives in medical products
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Guidance in the use of technical standards relating to the risk management, biological safety of Medical Devices and TEMPs / ATMPs (national, EN and ISO standards)
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Training courses & workshops on any of the above topics
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Relevant Experience:
Familiar with the regulatory issues associated with Medicinal Products, Medical Devices, Tissue Engineered Medical Products, Advanced Therapy Medicinal Products and Combination Products and their planned use in a broad spectrum of clinical wound types including traumatic injuries, surgical wounds (including skin graft donor sites), chronic wounds & scars.
Our regulatory affairs expert:
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is a Board Certified Toxicologist in USA & Europe
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has 30 years industrial experience in pre-
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has 28 years experience working on International Standards Bodies (Medical Devices, Nanotechnology & Regenerative Medicine).
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has 24 years experience working on wound management products
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With Clients worldwide, including:
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Multinationals
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FTSE 100
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Notified Bodies
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Regulatory Authorities, CROs, SMEs & University Spin-
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