Services
MARKET RESEARCH
Market Reports are tailored to suit the client’s needs, be that entry into a foreign market, analysis of the competition, market trends or product development research.
Country Market Reports:
Political economic climate & medical market, Healthcare systems, regulations and license requirements & emerging policy. Market forecasts, funding and investment opportunities, R & D initiatives, forms of distribution and key competitors. Contact lists of decision makers, trade and business links.
Product Development Reports:
Analysis of herbal medicinal remedies, including bibliographic evidence of traditional use and safety data. The potential market; viability of gaining a traditional herbal registration (THR) Certificate and product conception.
Competitor Reports:
Profiles and analysis, with key commercial indicators such as: product development, market placement, biotechnical viability, licence consent status, staffing, published company accounts, funding & investment and analysis of the client’s position within this market.
REGULATORY & POLICY AFFAIRS
Regulation and Policy Reports can be tailored to provide concise and current info on CAM and integrative medicine. For example Avena has compiled a report on The statutory regulation of herbalists in the UK and aided the National Institute of Medical Herbalists (NIMH) draft their consultation response on this issue.
Traditional Herbal Medicine Registration Scheme (THMRS) Advice and Strategy on current regulatory processes involved in introducing herbal products to market and industry requirements.
Traditional herbal registration (THR) Certification Avena Consultants can help you compile the required dossier including: Writing or proof reading patient information leaflets, compiling bibliographic/expert evidence of traditional use and safety data, plus advice on quality assessments.
Medical Writing Services provide high quality editing and scripting of medical literature, papers and patient information on health, lifestyle and traditional medicinal products.
Writing and proof reading: We structure medicinal product leaflets, packaging and labels. With a focus on readability for users whilst meeting the regulatory requirements for such information.
Integrative Health projects: We can provide content and copy on health initiatives and projects, as qualified herbalists we can use our extensive knowledge of clinical medicine, health, lifestyle and nutrition to communicate effectively with a non-medical target audience.
Advertising Support: Photo research and slogans for products and advertising copy and advice on meeting regulatory requirements for advertising medicinal products and labelling for traditional remedies.
TRADITIONAL HERBAL MEDICINES REGISTRATION SCHEME (THMRS)
Avena Consultants
can advise you on how to comply with the THMR Scheme and provide you with reports on the key requirements specific to your business and your products.
We examine the viability of your product for Traditional Herbal Registration (THR) Certification and whether or not it would be defined as too potent or ‘borderline’. We can help compile the required THR application dossier in the following ways:
Patient Information Leaflets (PILs):
Writing or proof reading mock up PILs, packaging and labels and making sure they meet legal requirements.
Advertising and Promotion:
Advertising photo research, slogans and advertising copy to meet the EU and UK Medicines (Advertising) Regulations.
Bibliographic or expert evidence:
We can compose this section of the dossier including checking herbs on the positive list being created by The EU Committee on Herbal Medicinal Products (HMPC). As fully qualified medical herbalists we can help you compile clinical and non clinical evidence of traditional use and safety data as set out by Directive 2004/24/EC.
Quality Assessment:
A traditional medicinal product does not have to prove efficacy, however it needs to comply with Good Manufacturing Practice (GMP) - Directive 2003/94/EC and an assessment of the ingredients to ensure acceptable quality, free from contamination and correct shelf life are met. Avena Consultants can advice you on this process and provide a list of laboratories that can carry out product testing.
