Our Services
EXDRA as renowned full service provider offers the following broad range of regulatory services:
Research & Development
- Early Scientific Advice with authorities
- Project planning
– according to international registration standards
– following Scientific Advice - Clinical Trial Application
– Investigator’s Brochure (IB)
– Investigational Medicinal Product Dossier (IMPD)
– Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) for Investigational Medicinal Products (IMPs) - Optimization of clinical research spending
- Project management
– Minimizing administrative burden by effective document management
Registration
- Support for in-house registration of Medicinal Products and Medical Devices
– Evaluation of good regulatory practice (GRP), Regulatory compliance and Quality Management (QM)
– Due diligence of existing in-house data/documents
– Evaluation of existing regulatory intelligence
– Analysis of regulatory requirements in target markets
– Development of an international registration strategy
– Pricing policies/ Pharmaco-economics
– Maximizing patent protection/SPC
– Business-optimized registration procedures: Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP) and single country procedure - External full-service provider
– Filing of US- and Japanese applications with partners
– Monitoring upcoming requirements
Manufacturing
- Good manufacturing and distribution practice (GMDP)
- Drug master files (DMF)
- Active substance master file (ASMF)
- Certificate of Suitability (CEP) issued by the European Directorate for the Quality of Medicines (EDQM)
- Worldwide Inspection Policy and Strategy
Business Development
- Merger and Acquisition (M&A) activities
– Company Due Diligence (Pharma, Biotech and Medical Device) - Business Development support
- Due Diligence of existing registration dossiers
- Regulatory life cycle strategy
Marketing and Sales
- Support in pricing strategies
- Pharmaco-economic modelling
- Health Technology Assessment
- Life cycle management
- Variations and extensions (new dosage forms, new strenghts, new indications)
- Optimized labelling
Further EXDRA Services
- exdra Academy
– In-house seminars
– Specialty workshops
– MSc based education - Human resources management
– Interims management
– Recruitment of necessary competence profiles
– Assessment of qualifications - Document management
– Process and workflow definition
– Software tool implementation