Independent Consultants to the Healthcare Industry
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PRODUCT REGISTRATION
- Preparation of dossiers for national and international product licence applications.
- Preparation of CTC / CTX applications.
- Preparation of Expert Reports / Overviews.
- Complete dossier reviews.
- Advice on regulatory affairs.
- Discussions with regulatory bodies.
- Representations at hearings with the authorities.
- Preparations of variations and renewals.
In order to achieve a successful marketing authorisation application the dossier needs to be:-
| Complete, accurate in detail, |
R & M Consultancy has prepared dossiers for marketing authorisation applications in the UK and other EC countries as well as South Africa, Pakistan, Poland, Hungary, The Czech Republic and the USA. We have also assisted in the preparation of data for product licence applications in Australia, Canada, Finland, Norway, Russia and Sweden.
Abridged applications, variations and renewals are also prepared for our clients.
Expert Reports / Overviews constitute a very important part of the registration dossier, therefore, it is essential that they are prepared by experienced staff. It is also advantageous to have a report prepared by an independent expert.
Sterling House, 3A New Street, Ledbury, Herefordshire, HR8 2DX. United Kingdom.
Telephone +44 (0) 1531 635008 Facsimile +44 (0) 1531 634844
E-mail : enquiries@rm-consult.co.uk Web : www.rm-consult.co.uk
