•
Identification of worldwide regulatory requirements
• On-line literature searches
• International network of local advisors
No
company can ever be aware of all the regulatory requirements
worldwide for every type of product. 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.
Wainwright
Associates has developed a network of local advisors in all the
major territories of the world. All are independent and can advise
not only on local regulations in their country, but also on current
attitudes prevailing within their national regulatory body.
Our
international regulatory desk research 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 innovative medicinal products as well as for
medical devices and borderline products.
Itemised
reports are prepared detailing regulatory requirements on a country-by-country
basis and providing appendices containing copies of specific legislation
and guidelines.
Network
of Local Advisors
We
have over 400 advisors in 50 countries; all are independent. Their
expertise covers human and veterinary medicines, medical devices
and in vitro diagnostics, herbal products and foods, cosmetics
and toiletries. They are located in the following territories:
| Argentina |
Denmark |
Ireland |
Moldova |
Slovenia |
| Australia |
Egypt |
Israel |
Netherlands |
South Africa |
| Austria |
Estonia |
Italy
|
New Zealand |
Spain |
| Belgium |
Finland |
Japan
|
Norway |
Sweden |
| Brazil |
France |
Jordan |
Peru |
Switzerland |
| Brunei |
Germany |
Korea |
Poland |
Taiwan |
| Bulgaria |
Greece |
Latvia |
Portugal |
Thailand |
| Canada |
Hong
Kong |
Lithuania
|
Romania
|
Turkey |
| Chile |
Hungary |
Luxembourg |
Russia |
Ukraine |
| China |
Iceland |
Malaysia |
Saudi
Arabia |
United Kingdom |
| Columbia |
India |
Malta |
Singapore |
Uruguay |
| Czech
Republic |
Indonesia |
Mexico |
Slovakia |
USA |