A Advice on regulatory strategy EU legislation Audits – for GMP, GCP and GPP status   B Batch release in the EU Bioequivalence study design Bioequivalence study monitoring     C Certificates of suitability Advice on and preparation of Clinical trial applications and desing Clinical trial monitoring Common Technical Document formats Centralised procedure applications (CP)     D Decentralised procedure applications (DCP) Drug Master Files Advice on and preparation of Due diligence activities     E Electronic submission of adverse event reports via Eudravigilance (EVWEB) Expert overviews (clinical, non-clinical and quality) Expert statements for variations Expert witness Export certificates (Certificate of Pharmaceutical Product applications) eCTD dossier preparations     F Full service from product conception through to post-marketing Facility auditing of bioequivalence study clinical facilities     G Generic drug developments and registration Good Manufacturing Practice (GMP) Good Pharmacovigilance Practice (GPP)     H Holding MAs for companies     I Interfacing with regulatory authorities Inspection preparation     J Journal articles and reprints ordering     K Knowledge of EU legislation     L Labelling advice and preparation Literature surveillance for pharmacovigilance Leaflet User Testing (working with our preferred providers)     M Manufacturer’s and wholesale dealer’s licences Marketing Authorisation Applications Medical Product Dictionary submissions via Eudravigilance (EVWEB) Medical writing Mutual Recognition Procedure applications (MRP)     N National applications     O Organisational Structural review and analysis OTC strategy (advice on POM to P submissions)     P Periodic Safety Update Reports Pharmacovigilance PIL (Patient Information Leaflet) preparation Product recalls Project management     Q Qualified Person (QP) support Qualified Person for Pharmacovigilance (QPP) support     R Regulatory authority meetings Regulatory consultancy Renewals     S Scientific data assessment Signal detection for pharmacovigilance Standard Operating Procedures Strategic consulting Summary of Product Characteristics preparation SUSAR reporting for clinical trials via Eudravigilance (EVWEB)     T Traditional herbal medicines registration     U Understanding of customer priorities and needs     V Variations .     W Wholesale Dealers Licence applications