Regulator-e Associates Ltd provides expert regulatory
support and training to the Pharmaceutical Industry.
Providing quality documentation is not enough for us at
Regulator-e Associates. Each client project is evaluated to ascertain the optimal
solution, this normally means taking into account scientific and technical progress
through due diligence exercises and in-depth research of the ever-changing
Pharmaceutical Industry.
REGULATORY SUPPORT
Document Preparation:
MAA conversion to CTD format
Marketing Authorisations - European/International -
Mutual Recognition, Centralised or National procedures
National, European and International guidelines and
updates
Regulatory Training:
MAA conversion to CTD format
Basic Introduction to Regulatory Affairs
Understanding the European Market - Mutual Recognition
and Centralised Procedures
Clinical Trial Application requirements in the EU
(2001/20/EC)
Understanding the International Regulatory Environment
Regulator-e Associates offers a multitude of tailor
made courses for the Pharmaceutical Industry, whether
you are a start-up company or a multi national, please
feel free to contact us with any regulatory support or
training issues you require.
