Abbreviated Drug Application Abridged ApplicationsAdvertising and promotional material reviewAdvisory meeting preparationAppealsArtwork services from design to printing Assembly Licences Audit preparation and mock audits Basic regulatory training Bibliographic ApplicationsBio-similar & Biotechnology Pharmaceuticals ApplicationsBiotechnology advice and applicationBorderline Products Braille Bridging reportsCentralised Procedures Certificate of suitability applications Certificate of Pharmaceutical Product Change in Legal StatusChange of Ownership submissionClinical Advice/ExpertsClinical overview writingClinical summary writingClinical Trial Applications CMC reviewsContract QP ServicesCTD formatting and conversionDecentralised Procedure Designing and complaint packaging leaflets and labellingDevelopment strategyDossier Preparation and/or ReviewingDrug-device combination products applicationDrug Master FileDue Diligencee-CTD Management EDMFEDQM notification, renewalsEnvironmental Risk AssessmentEuropean DCP applicationsEuropean DCP licence maintenance European MRP applicationsEuropean MRP licence maintenanceExceptional circumstances applicationExpert report written e.g. pharmaceutical, clinical and non-clinical Export Certificates e.g. CP and Free Sales CertificatesFiling StrategyFree Sales CertificateFDA 483 / Warning Letter ResolutionsFiling strategy'sFocus TestingGap analysisGCP, GLP and GMP inspectionGeneric applicationsGeneric renewalsGeneric variationsGroup trainingGSL medicinesHerbal MedicinesHomeopathicHuman MedicinesHybrid MAAInvestigational Medicinal Product Dossier preparation, reviewing, updatingIn-house PlacementInterim Management Investigational New Drug preparationInvestigator Brochure reviewing, updatingISO 9001:2000 audits and audit preparationsJJapanese applications and maintenance Languages - Native European SpeakersLeaflets and Labelling - review, translation Liaison with Competent Authorities- Regulatory AuthoritiesLicence Maintenance (Renewals, Variations, PSUR's, etc)Licensing In/Out - Due diligence Line ExtensionsLine listings Literature searches/review Manufacturer's LicenceMarketing Authorisation Application Marketing Authorisation MaintenanceMedical device, drug-device combination products applicationMedical WritingMock audit inspections Module 1, 2, 3, 4 and 5 CTD conversions and/or compilationsMutual Recognition Procedure Applications Mutual Recognition Procedure licence maintenance throughout the EU <p