Global Regulatory Intelligence
Our global regulatory intelligence service can identify and advise on local regulations and provide national input into regulatory projects.
It is hard for any company to be aware of all existing regulatory requirements worldwide for every type of product especially as regulations and legislation are constantly being updated and new guidelines created. The international harmonisation process means that new procedures are always being developed and adopted by world regulatory authorities.
Our team of experienced and qualified consultants regularly work closely with our network of local advisors to ensure the information given to our clients is accurate and most current.
Wainwright Associates have developed a network of local advisors in all the major territories of the world, comprising over 60 countries, including emerging markets. All are independent and speak the local language and can advise not only on local regulations in their country, but also on current attitudes prevailing within their national regulatory body.
Our global regulatory intelligence service is designed to provide up-to-date guidance on local regulatory requirements for products under development. It is particularly valuable for novel dosage forms and high tech products as well as for devices and borderline products.
Regulatory Intelligence is designed to answer:
- What are the latest registration requirements in specified countries?
- Where can I obtain copies of relevant legislation?
- Are there any relevant guidelines?
- What are the current application fees?
- What language requirements apply?
- How long does the registration process take?
- Who is the appropriate contact at the authorities?
- What is the prevailing attitude towards a particular product type?
- Will a particular country accept the Common Technical Document?
- What is the local procedure for obtaining reimbursement?
- What is the mechanism for pricing approval?
- What effect will local harmonisation efforts have on my marketing strategy?
- What are the requirements for making electronic submissions?
- Does my product need to be registered?
- Is my product a drug or a device?
- What special considerations apply to borderline products?
- Are there any similar products on the market?
- Is there a special procedure for herbal products?
- Does my cosmetic label avoid medicinal claims?
- Is our clinical development strategy appropriate?
- Are there any patent restrictions?
- Can you find a local manufacturer or distributor?
- Where can we conduct local clinical trials?
- Do you have a local agent who can liaise with the authorities?
- Do you have translation capabilities?
- Can you source a raw material?
- What safety data are available on my product?
- Are there local differences in medical practice?
- What changes are expected in the coming years?
Itemised reports are prepared detailing regulatory requirements on a country-by-country basis and providing appendices containing copies of specific legislation and guidelines.