2. Euro Pharma Bridge
We are a strategic alliance between leading service providers with the scope
of facilitating European Market Access to pharmaceutical manufacturers
from non European countries.
We provide added value services covering all steps from business case to
market.

3. European Market Access

4. The process and the service providers
Licensing Support Compliance Regulatory Support Import and Batch
Release
Marketing and Sales
Experts
Logistics

5. Licensing Support
• Portfolio evaluation: licensor’s portfolio screening with the aim to identify the
most appropriate products to be introduced into the targeted marketplace.
• Market analysis: therapeutic groups and main players‘ sales volume,
evolution, pricing issues, trends, etc.
• Licensing out: profiling of potential distributors, identification and
appointment advice.
• Alliance Management: termsheet drafting, contract negotiation,
implementation and followup after agreement signature with the aim to
maximize product sales.

6. • Quality Systems design and development
• Design and qualification of GxP facilities,
equipment and services
• GxP audits and GAP analysis
• Preparation of action plans for GMP, GLP,
GCP compliance
Compliance
• Preparation of Health Authorities inspections
• Computerized Systems validation
• Validation of manufacturing and cleaning
processes
• Training programs

7. Regulatory Support
• Regulatory Support and Feasibility Assessment
during Development
• Regulatory Strategy for European and
Worldwide Submissions
• Writing and Authoring of all Technical and
Scientific Documentation
• Submission Management for all Regulatory
Procedures
• e-Submission Expert Services
including all Electronic Gateways
• Pharmacovigilance Services
• Optimised Product Maintenance

8. Import and Batch Release
• Import of medicinal and investigational
drug products into the European Union
• QP Declaration for Submission
• Batch testing of pharmaceuticals and
biologics
• Batch release
• Bioequivalence studies
• Bioanalysis of innovative drugs and
immunogenicity studies
• Characterization of biologics and
comparability of biosimilars
• Analytical development and validation for
drug substances and drug products
• Stability Studies
• Quality Control of pharmaceutical ingredients

9. Marketing & Sales Experts
• Marketing Plan, SWOT, Positioning, Rolling
Forecast and Action Plans
• Graphic design of packaging materials
• Marketing and promotional materials
• Advisory boards: creation, development,
analysis and conclusions
• Outstanding sales force services
• Organization of Launch meetings and
events
• Reps Training
• Webs, education platforms, social media,
etc,…

10. Logistics
• Warehousing and order preparation
• Distribution to hospitals, pharmacies and wholesalers
• Direct to pharmacies distribution
• Order-to-cash, front and back office management
• Sales and marketing support in the promotion to pharmacies and hospital channels
• Secondary manufacturing
• Clinical trials management
• Home delivery and adherence to the treatment management