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Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms, and generics both in the UK and using EMEA and the EC mutual recognition system. Expert has expert knowledge of the essential similarity rules and how they can be used to defend and protect clients from competitors. Expert is experienced in obtaining CE marks for medical devices including dental products and Class III products, in vitro diagnostics (IVDs) and obtaining UK reimbursement. Without government reimbursement sales of any medical device or IVD will be severely restricted. Expert also has successful experience in advising cosmetic companies on labeling and regulatory issues within the EU and those producing borderline substances. An Authorized Representative service for cosmetics, medical devices and IVDs can also be provided.

Expert has over 30 years of experience in the registration of medical devices, ranging from wound dressings to orthopaedic implants and contraceptive devices. He has considerable experience with the European Community (EC) Medical Device Directive, which covers Class I through Class III devices, including devices that contain an active drug substance. as well as with the FDA. Expert can advise on the implementation of the Active Implantable Medical Device Directive (AIMDD). He has also worked with many "Notified Bodies," and "Competent Authorities." In addition, he has experience in classification, risk analysis, and regulatory appeals. Also acts as an expert witness. Authorised representative service can be provided.

Over the past several years Expert has dealt with registration and reimbursement issues for in vitro diagnostics. Expertisel with the EC In Vitro Diagnostics Directive 98/79/EC.

Expert has expert knowledge of the UK reimbursement legislation and success in obtaining the UK reimbursement for many appliances, drugs, devices, medicines, reagents, dermatologicals, foods, and drug/device combinations. In particular, Expert has successful experience in obtaining reimbursement at public expense for osmotic products, wound care materials, and contraceptives. He can also advise clients on strategies to obtain reimbursement of borderline substances such as foods and cosmetics. Acts s an expert witness with respect to Appeals.

Expert has successfully registered several veterinary drugs in the UK, including vaccines, topical products, and aerosol presentations.

Expert has expert knowledge of herbal medicines and related niche areas within the USA, United Kingdom and the EC.

Due to his excellent background, Expert is highly qualified and experienced to handle drug-device combination products on a pan-European basis.

Over the years, Expert has successfully advised numerous companies regarding their regulatory and marketing strategy within the EC. He can assist with developing strategies to delay or help generic entry in order to optimize profits on a pan-European basis.

Expert has devoted 30 years representing various interests on British Pharmacopoeia working parties, drafting CEN standards, and making representations to European Pharmacopoeia for both pharmaceuticals and devices.

Expert has assisted numerous health care companies in implementing ISO 13485 quality systems with a view to obtain a CE mark.

Expert has experience introducing new products and even acquisition prospects to a wide spectrum of companies, including start-ups and new ventures.

Expert has advised and assisted many U.S. companies entering the EU on developing new dosage forms that will be medically and commercially acceptable within the EU.

Expert employs a team of regulatory specialists who can handle a broad spectrum of issues.

Expert can prepare all stages of FDA and EU marketing authorization applications for EU Member States or via EMEA.

Expert has 30 years experience with EU drug and drug/device registration.

Expert's company can provide stability testing to EU standards for solid and liquid dosage forms with the exception of vaccines, aerosols and ampoules. They can also develop stability indicating methods for most active substances.

Expert has acted as an expert witness in matters relating the legal requirements for drug testing.

Expert has current experience in drafting US, UK and EU patent applications.

Expert can act as an advisor and expert witness on EU Directives relating to drugs, devices, cosmetics and some aspects of compeition law.

Expert can assist clients in drafting mid-level quality management systems and also standard operating procedures to EU/ISO standards.

Expert can advise on the strategies adopted in the UK for healthcare and means of using the system to the advantage of the client particularly with respect to pricing and government reimbursement issues.

Expert has obtained CE marks for many types of medical device including Class III medical devices that contain an active pharmaceutical substance.

Expert can advise on the validation of new process procedures.

Expert will advise on how medical devices can be modified or improved to obtain greater market share.

Expert can find and recommend relevant EU-based test houses for these purposes and advise on approiate test methods.

Expert will act as the reporter to Competent Authorities for the EU vigilance system i.e. authorised representative service and act as the USA representaitve for the FDA.

He can advise on EU medical device reporting requirements.

Expert has current experience in obtaining UK and EU Marketing Authorizations (MAs) for OTC medicines as well as in the USA.

Expert can advise on NICE investigations in the UK and macro changes in the market and development novel cost effectiveness strategies.

Expert can advise on medium- and long-term strategic changes in the UK market and how best to take advantage of those changes.

He has obtained UK reimbursement and CE marks for dozens of wound care products and holds two patents for novel wound irrigation solutions. He has published several papers on wound healing and also the reimbursement of wound healing products in the UK.

Expert operates an EU Authorized Representative Service for non-EU based companies wishing to establish themselves within the EU.

Expert has expert knowledge of obtaining public funding for borderline substances such as foods, nutraceuticals and cosmetics.

Expert is very knowledgeable and can assist in this area. He notes that no medical device or IVD is automatically reimbursed at public expense in the UK even though a CE mark may have been granted. The UK operates a "white list" of branded products that can be prescribed at public expense in the community by doctors and Nurse Prescribers. Unless a medical device/IVD is listed in the UK white list of appliances known as the Drug Tariff, then the demand for the product will be virtually nothing, as patients in the UK will generally not pay privately for medical devices and IVDs.


Expert advised Pfizer to seek a Judicial Review concerning Viagra.He advised Aventis on reimbursement and pricing issues. Expert obtained reimbursement for 3M Micropore tape at premium prices.He obtained Marketing Authorization (i.e., official marketing approval) and reimbursement for calcium alginate. Expert acted as an EU Authorized Representative for many device and cosmetics companies at early stages of EU marketing.