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Honeyman PCS |
Regulatory Affairs
HPCS are able to support
most product and licensing initiatives. In particular, the following services
can be provided:
Drug Master Files (DMF)
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Compilation of
European Type A, C, D Drug Master Files
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Preparation
and submission of Certificates of Suitability (CEP) for pharmacopoeial
substances to the EDQM for approval
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Compilation of
US FDA DMF documentation for actives, excipients, packaging materials etc
Site Master Files (SMF)
Product Licensing
Pharmaceutical products can
only be commercialised after Marketing Authorisation (MA) has been granted by
the Competent Authorities. For the European market, this approval is granted
based on the submissions contained within the market authorisation application (MAA),
the content of which is governed by Directives 75/318/EEC, 91/507 EEC and the
applicable Notices to Applicants and Notes for Guidance. In recent years, such
MAA submissions are required to be made using the ICH4 CTD format of 5 modules.
HPCS are able to offer a
comprehensive service including:
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Planning of
the Market Application strategy
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Compilation of
the CTD registration dossier/submission and support of the MAA during the review
period
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Preparation of
the Expert Reports required by CTD Module 2
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Assistance in
addressing MAA questions and concerns from the Regulatory Authorities
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Preparation of
post-approval change documentation (EU Type 1/2) to an existing market
authorisation
Clinical trials
It is a requirement of
European Directive 2001/20/EC that clinical trials on medicines for human use
may not begin until the appropriate Ethics Committee has issued a favourable
opinion. Submission to certain national Ethics Committees must include more
detailed information on quality and preclinical aspects contained in the
Investigational Medicinal Product Dossier (IMPD). HPCS can assist in the
compilation, review and submission of IMPD documentation.
Qualified Person
All medicinal products
distributed within the European Union, whether manufactured inside the community
or imported from third countries must receive a Qualified Person release (Annex
16) inside the EU. HPCS is able to provide full QP support services (subject to
the approval of the local Competent Authority).
Return to GMP Regulatory Compliance Life Cycle |
