Advisory service for human therapeutic products.
Professional advice and guidance by selected international experts to meet the challenges of the regulatory standards.
What we do
Soho Links connects the knowledge and expertise of specialist advisers with you
– to meet the evolving standards and latest developments.
We provide technical and regulatory expertise to organisations working with substances of human origin (SoHO) to achieve and maintain the regulatory requirements and modern standards. If your projects involve the application of regulations, standards or guidance for human tissues and cells, or for assisted reproductive technologies, then we can assist you.
Our services include reviews of Quality Management Systems, compliance assessments, project management by a team of advisers and the achitecture of IT systems. We also provide advice on specialist processes, risk management models, registration of establishments at European Competent Authorities and the state of play on novel therapeutic products. For National Competent Authorities we can provide advice on the licensing and inspection processes, systems for annual reporting and the training of specialist inspectors.
These may benefit your own healthcare organisation and the standards of care to patients. We look forward to hearing from you.
Soho Links was established to connect our professional advisers with healthcare services and private organisations for the management of substances of human origin (SoHO).
The primary mission of Soho Links is to achieve high standards for the quality, safety and efficacy of therapeutic products for optimal benefit to patients.
Our advisors are highly experienced experts with recognised technical experience and practical knowledge of specialist subjects applicable to a broad range of SoHO matters.
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Co-Founders of Soho Links
Mike has been an active participant and negotiator for the Quality, Safety & Efficacy of human tissues & cells, as well as blood and blood components. As a Lead Assessor in Quality Management Systems, the sector interface of therapeutic products utilising human derivatives/substances are of particular interest. Mike has 24 years experience in contributing to a series of harmonisation initiatives (e.g. EUSTITE, SOHOVS, IES) and regulations as the national representative at the European Commission (EC) fora, as well as being an active supporter and contributor to the review of the SoHO regulatory framework. Mike is enthusiastic as a senior tutor and mentor at training courses for EU inspectors and presents topical subjects at several Professional Society conferences. (Function: Web administrator).
Imogen has been involved in the regulation of tissues, cells and organs for over 18 years. For ten years Imogen was a Head of Regulation for the Human Tissue Authority (HTA) and responsible for ensuring that establishments working with substances of human origin (SoHO) met the required standards of quality and safety. Imogen has a wealth of experience in developing robust inspection and licensing systems and leading complex inspections. Imogen also has extensive experience in developing organisational policies and strategies. As the UK representative at the European Commission (EC) Imogen has been actively involved in numerous EU harmonisation initiatives, as well as working closely with the EC during the drafting of EU Directives associated with SoHO (Function: Adviser).