Last update Nov 2015
PharmaQM
 

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Regulatory issues for pharmaceutical development

A pharmaceutical consultancy based in the United Kingdom providing

  • expert regulatory advice and insight on medicines licensing [gaining and maintaining Marketing Authorisations (MAs)] and associated procedural and technical strategies

  • Expert Witness statements on Chemistry, Manufacturing and Control (CMC) subjects

  • internal (in-company) and external (public) staff training on pharmaceutical regulatory legislation, guidelines and licensing / post-licensing policies for medicinal products in the EU

to the chemical and pharmaceutical industries.

REGULATORY STRATEGY
ADVICE
DOSSIER PREPARATION AND GAP ANALYSIS
ACTIVE SUBSTANCE MASTER FILES (ASMFs)
CERTIFICATE OF SUITABILITY (CEP) DOSSIERS
IN-COMPANY / IN-HOUSE STAFF TRAINING
EUROPEAN PHARMACOPOEIA / BRITISH PHARMACOPOEIA