Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at


Expert Details

Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness

ID: 107649 Oklahoma, USA

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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.


Year Degree Subject Institution
Year: 2004 Degree: PhD Subject: Health Economics Institution: Canterbury Univeristy
Year: 1968 Degree: MSc Subject: Marketing Economics and Statistics Institution: Manchester University
Year: 1967 Degree: BA Subject: Social Sciences and Statistics Institution: Nottingham University

Work History

Years Employer Title Department
Years: 1979 to Present Employer: Undisclosed Title: Consultant Department: Registration/Marketing
handles the registration of drugs, devices and drug device combinations in both Europe and the USA. Company is the only UK consultancy to specialize in reimbursement issues, as far as we
are aware. The undersigned has been a member of three British Pharmacopoeia Working Parties and on various BSI Technical Committees. Now employs a team of regulatory consultants with
clients based all over the world.
Years Employer Title Department
Years: 1972 to 1973 Employer: Sherwood Medical Industries Title: Product Manager Department: Syringes, Needles catheters
Marketing reimbursement of sterile syringes needles and catheters.
Years Employer Title Department
Years: 1970 to 1973 Employer: 3M and Riker Labs Title: Product Coordinator Department: Medical and Dental Products Division/Riker
He was involved in the marketing of 3M Riker drugs and some medical/dental devices.
Years Employer Title Department
Years: 1968 to 1970 Employer: BRITISH OXYGEN CRYOGENICS DIVISION Title: Marketing Assistant Department:
Expert provided marketing support for cryogenic gases and containers.

Government Experience

Years Agency Role Description
Years: 1990 to 2007 Agency: U.K. Department of Health Role: Description: Expert has coordinated or advised on ten successful legal actions against the U.K. Department of Health, including the Viagra case. Also involved in legal reviews of drug device issues with the MHRA

International Experience

Years Country / Region Summary
Years: to Present Country / Region: USA Summary: Expert advised many private and public companies on EU regulatory, development and production issues
Years: to Present Country / Region: France Summary: He advises Les Laboratoires Brothier on registration and reimbursement issues.
Years: to Present Country / Region: Switzerland Summary: Expert advises several Swiss pharmaceutical companies on EU/UK registration and reimbursement issues.
Years: to Present Country / Region: Italy Summary: He advises two Italian companies on registration and U.K. pricing/reimbursement issues.
Years: to Present Country / Region: Africa Summary: Expert advises Xechem International Inc and Natracine Ltd on production, development and regulatory issues in Nigeria and South Africa.

Career Accomplishments

Associations / Societies
Expert is a Fellow of the Royal Society of Medicine and a member of the Expert Witness Institute
Publications and Patents Summary
He has three healthcare patents and seven peer-reviewed scientific publications.

Additional Experience

Expert Witness Experience
Expert acted as coordinator and/or as an expert witness in several successful Judicial Reviews concerning U.K. reimbursement of drugs and devices. Currently acting as expert witness in the determination of drug device issues.
Member of the expert witnesss Institute
Training / Seminars
Has given several seminars on wound care products and compression hosiery products
Vendor Selection
Expert has experience locating vendors of clinical trials, stability testing, drug product testing, pharmaceutical reformulation, pharmaceutical distributors, placebo manufacture, sterilization processes, medical expert reports, bulk active ingredients and excipients, and market research.
Marketing Experience
Expert is the CEO of a firm that will act as an EU Authorized Representative for drugs, devices, cosmetics, and IVDs.
Other Relevant Experience
Will act as non-executive director of US pharmaceutical and or medical device companies that need international experience of development, registration and reimbursement issues.

Language Skills

Language Proficiency
German Expert has near fluent skills in German. In addition, he regularly advises clients in Germany, France, Italy, Sweden, Denmark, Iceland, and Hungary.
French Expert is near fluent in French.

Fields of Expertise

European drug registration, in vitro diagnostics, CE Marking, foreign medical device regulation, In Vitro Diagnostics Directive 98/79/EC, United Kingdom healthcare expense reimbursement, Current Procedural Terminology, animal vaccine, herbal product, medical device product development, European marketing, strategic planning, ISO 9000 implementation, acquisition, drug dosage form development, drug labeling requirement, drug product approval, drug regulation, drug stability, drug testing statute, European patent, European statute, health care industry quality management, health care system, medical device, medical device process validation, medical device product improvement, medical device reliability testing, medical device testing, medical device reporting, Medical Device Reporting regulation, over-the-counter drug regulation, pharmacoeconomics, strategic market planning, wound healing, European Union Authorized Representative, health care marketing, United Kingdom borderline substance, United Kingdom medical device reimbursement, European Community Sixth/Seventh Amendment, European Inventory of Existing Commercial Chemical Substances, European labeling requirement, European manufacturing, European safety directive, European safety standard, FDA medical device regulation, food, oral surgery, orthodontics, pediatric dentistry, preventive dentistry, dosage, adverse drug reaction, medical reimbursement, herbal toxicity, product pricing, marketing mix, European market research, pharmaceutical technology, European electrical standard, bulk drug, over-the-counter topical drug product development, over-the-counter drug product development, pharmaceutical manufacturer, drug formulation, pharmaceutical research and development, pharmaceutical product development, in vitro toxicology, stability testing, medical device auditing, drug validation, drug clinical trial, biotechnology assessment, medical device clinical research, pharmaceutical product formulation, pharmaceutical intermediate, drug safety testing, pharmaceutical quality assurance, pharmaceutical research, medical diagnostics, drug development, pharmaceutical industry, biotechnology quality assurance, biotechnology market research, drug analysis, medical diagnostic test development, European standard, pharmaceutical quality control, European Committee for Standardization, drug delivery, medical device manufacturing, medical device design, pharmaceutical drug, sunscreen, pharmaceutical manufacturing, over-the-counter drug, drug screening, bulk pharmaceutical chemical manufacturing

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