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 Expert  107649

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

Available for your Consulting and Expert Witness Needs

Oklahoma (OK)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
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 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.


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



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.


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




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




oral surgery




pediatric dentistry


preventive dentistry

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Oklahoma City, Oklahoma;  Tulsa, Oklahoma;  Norman, Oklahoma;  Lawton, Oklahoma;  Broken Arrow, Oklahoma;  and Edmond, Oklahoma.

Often requested
with this expert:

Pharmaceutical Technology, Manufacturing, Quality Systems...
FDA Regulatory Consultant for Medical Devices, Cosmetics,...
EU GMP and Quality Systems
Machinery CE-Marking, Medical Device CE-Marking, CE-Marking...

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

Work History:
Years   Employer   Department   Title   Responsibilities

1979 to 2011


Expert Associates






2007 to 2010


Xechem International Inc





He is responsible for the Supervision of production, regulatory and development issues both in USA and Nigeria.

1972 to 1973


Sherwood Medical Industries


Syringes, Needles catheters


Product Manager


Marketing reimbursement of sterile syringes needles and catheters.

1970 to 1973


3M and Riker Labs


Medical and Dental Products Division/Riker


Product Group Manager


He was involved in the marketing of 3M Riker drugs and some medical/dental devices.

1968 to 1970


British Oxygen


Cryogenics Division


Marketing Assistant


Expert provided marketing support for cryogenic gases and containers.





Medical Products Division


Product Group Manager


specialized in the UK reimbursement of medical devices and marketing to the medical profession.

Career Accomplishments:

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.

Selected Publications and Publishers  
 - European Wound Management Association Conference  
 - Regulatory Affairs Journal  
 - Chemist and Druggist  

Government Experience:
Years   Agency   Description
1990 to 2007   U.K. Department of Health   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

Consulting Services:
Selected Consulting Examples:
  • 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.
Recent Client Requests:
  • Expert in CE markings for consulting on acquisition of CE marketing for US based foam swab manufacturer.
  • UK pharmaceutical expert for consulting on registration of OTC drugs and cosmetics.
  • Expert in borderline substances in the UK for consulting on how to successfully make a submission to ACBS.
  • EU cosmetic expert for consulting on soap formulas and antimicrobial soap formulas for export to Europe.
  • EU pharmaceutical expert for consulting on European approval for a homeopathic drug.
  • Expert in European statute for consulting on EU cosmetics registration.
  • Expert in Borderline substances UK.
  • Expert in otc europe drug resistration for consulting on OTC EU Registration Guidleines.
  • Emea expert for consulting on Veterinary (MUM's) registratrion in EU.
  • Expert in how to register cosmetics in France for consulting on EU Cosmetics Registration.
  • Expert in drug registration in europe for consulting on Drug Registration.
  • Expert in OTC registration in europe for consulting on topical ibuprofen.
  • Expert in cosmetic registration france for consulting on Registration licensing of cosmetic product in France (EU).
  • Consultation on FDA cosmetic regulatory compliance.
  • Expert for consulting on Inforequest: 'Borderline Products'.
  • Expert in spray drying toll work new york for consulting on Moringa leaf powder spray drying.
  • Expert in personal hygiene products for consulting on the registration of anti-lice product in the UK.
  • Expert in pharmaceuticals for consulting on entering the EU market.
  • Class I Medical Device registration expert in France for consulting on registration of a class I medical device in Europe.
  • EU cosmetic expert for consulting on advising CTO to meet 76/768/EEC requirements.
  • Expert in veterinary products for consulting on vaccines and diagnostics for animal production.
  • Expert for consulting on Teflon and Regulations.
  • Expert for consulting on PuraCap Pharmaceutical - S. Plainfield, NJ.
  • Regulatory expert herb topical emulsion for consulting on regulatory for herb-based topically applied product.
  • Expert in European drug Filing and Registration for consulting on Training.
  • Expert in pharmaceutical and consumer products registration.for consulting on project feasability.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
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
Recent Litigation Client Requests:
  • European union directives expert for consulting on EU, UAE and Member State Laws Governing the Sale of Electronic Cigarettes.
  • Expert witness MHRA for consulting on EMA/MHRA.
  • Expert for consulting on anti-aging cream false claims
  • Expert in lithium-ion battery used in an e-cigarette which exploded during use.
  • FDA expert in medical devices for consulting on products liability litigation.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

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

Language Skills:
Foreign Language   Description
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.

Market Research:
Expert is the CEO of a firm that will act as an EU Authorized Representative for drugs, devices, cosmetics, and IVDs.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:

Has given several seminars on wound care products and compression hosiery products

Supplier and Vendor Location and 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.

Other Skills and Services

Will act as non-executive director of US pharmaceutical and or medical device companies that need international experience of development, registration and reimbursement issues.


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