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A To Z Of Regulatory Services
| 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 design 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 |