•
Writing chemistry/pharmacy, preclinical and clinical texts
• Clinical trial authorisations
• Preparation of regulatory submissions
• Expert reports/overviews
• EU centralised and mutual recognition procedures
• Liaison with EMEA and national regulatory authorities
• Manufacturers and Wholesale Dealers Licences
Wainwright
Associates has handled many regulatory submissions, in
many different countries, on behalf of client companies. These
include clinical trial authorisations, marketing authorisations
and manufacturers’ and wholesale dealers’ licences.
Under
harmonised medicines legislation in the European Union
two routes of registration are possible:
•
Centralised Procedure
• Decentralised Procedure (from November 2005)
• Mutual Recognition Procedure
The
experienced Wainwright Associates team is qualified to
advise on all the scientific disciplines required for successful
registration in the EU and other territories. The team's vast
regulatory experience includes many approvals via both Centralised
and MR routes for multinationals as well as virtual companies.
We have established excellent working relationships with
translators and reprographics companies to ensure high quality
dossiers meeting EU requirements. Our quality control methods
are first class. We also understand the importance of prompt and
secure despatch of dossiers to the authorities.
Our extensive experience allows us to advise on the submission
route and success factors in getting the application right first
time.
Centralised Applications
The Centralised Procedure is mandatory for biotechnological
products, products for orphan indications and new drugs for AIDS,
cancer, diabetes and degenerative diseases. It is optional for
certain other innovative medicines. The single Marketing Authorisation
granted under the Centralised Procedure is valid in all EU member
states.
Wainwright Associates can assist in many ways:
• Organising and attending a pre-submission meeting
at the EMEA
• Recommendation of Rapporteur and Co-rapporteur
• Advice on acceptability of trade names
• Preparation of marketing authorisation application
• Submission of dossier and payment of fees
• Assuring validation of the dossier
• Submission of dossier to CHMP members on request
• Receiving questions and preparation of suitable responses
• Co-ordination and submission of responses
• If necessary, arranging an oral explanation, accompanying
the client
• Organising final translations of SPC, PIL and labels in
all official languages
• Submission of colour mock-ups.
Decentralised and Mutual Recognition Applications
The Mutual Recognition Procedure allows a Marketing Authorisation
already granted in one member state (Reference Member State) to
be recognised in some or all of the others (Concerned Member States)
by the granting of national Marketing Authorisations.
The Decentralised Procedure applies to products for which
the Centralised Procedure is mot mandatory and which are not authorised
in any EU member state. It facilitates the parallel submission
to both Reference Member State and Concerned Member States with
parallel granting of national Marketing Authorisations.
The activities we cover are listed below:
•
Comparison of Summaries of Product Characteristics
• Organisation of meeting with Reference Member State, accompanying
the client
• Updating the dossier including Expert Reports/Overviews,
if necessary
• Obtaining the Assessment Report from the RMS
• Arranging translations and preparing documentation for
each Concerned Member State
• Organising payment of fees
• Co-ordination of pagination, photocopying, binding, and
despatch of dossier to the authorities
• Assuring validation and clock start
• Collecting questions from the authorities and preparation
of responses
• Co-ordination and submission of responses and liaison
with the authorities until grant of marketing authorisation
• Clarification of concerns and deficiencies at Co-ordination
Group
• Preparation and submission of mock-ups for finalised Patient
Information Leaflet and labels
• Advice on arbitration process
