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Regulatory Affairs Consultancy

Preparation of non-clinical overview section of Common Technical  Document (CTD) for worldwide licensing of Medicinal Products (drugs)

Guidance on pre-clinical testing requirements for Medicinal Products,  Medical Devices and Tissue Engineered Medical Products (TEMPs)/  Advanced Therapy Medicinal Products (ATMPs) and Combination  Products

Design, monitoring, reporting and interpretation of preclinical & non- clinical studies for Medicinal Products, Medical Devices & TEMPs/  ATMPs

Preparation of expert reviews of materials, their chemical safety &  toxicology for medical applications

Preparation of responses to regulatory authorities on safety,   biocompatibility & toxicology questions

Guidance on regulatory developments & advice on proposed use of  animal or human tissues or derivatives in medical products

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)

Training courses & workshops on any of the above topics
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:

is a Board Certified Toxicologist in USA & Europe
has 30 years industrial experience in pre-clinical R&D, Safety Evaluation, Regulatory Compliance, & Training
has 28 years experience working on International Standards Bodies (Medical Devices, Nanotechnology & Regenerative Medicine).
has 24 years experience working on wound management products
With Clients worldwide, including:
FTSE 100
Notified Bodies
Regulatory Authorities, CROs, SMEs & University Spin-outs

wound healing regulatory affairs
Wound Healing/Product Development Regulatory Affairs Wound Microbiology