Marketing authorisations
- Regulatory strategy
- National applications
- Mutual Recognition Procedure (MRP) applications
- Decentralised Procedure (DCP) applications
- Renewals
- Variations
- Notifications
Our servicesThe expertise you need.
The expertise you need.
At each stage.
Specialist services for medicinal products, medical devices and food supplements, with dedicated laboratory and pharmacovigilance support.
Regulatory affairs
Experienced support for marketing authorisation applications and post-marketing regulatory obligations for medicinal products.
We work to the highest regulatory compliance standards, providing services for medicinal products, medical devices and food supplements.
Expert services
- Quality (Module 2.3)
- Non-clinical (Module 2.4)
- Clinical (Module 2.5)
- Translation of product information
- Readability user testing
Additional regulatory services
- Mock-up preparation and proofreading
- Review of promotional materials
- eCTD preparation
Pricing & reimbursement
Support with pricing strategy, dossier preparation and interactions with the authorities.
- Selection of the ideal pricing strategy
- Writing pricing and reimbursement dossiers
- Submissions to the authorities
- Support in price negotiations
Pharmacovigilance
Flexible pharmacovigilance services with 24/7 availability.
People & systems
- EU Qualified Person for Pharmacovigilance and deputy
- Local Contact Person for Pharmacovigilance and deputy
- 24/7 availability
- PV system development and maintenance
- PSMF preparation and maintenance
Safety activities
- ICSR management
- Signal management
- PSURs
- RMPs
- Literature monitoring
- DHPC management
- Regulatory intelligence
Training & consultancy
- Pharmacovigilance training
- PV agreement development and maintenance
- Support with additional risk minimisation measures (aRMM)
- Pharmacovigilance consultancy
Drug safety contact · 24/7+359 892 290 915safety@medtr-bg.com
Laboratory analyses
A GMP-certified control laboratory focused on high-quality analytical services.
We analyse APIs, excipients and finished drug products in accordance with GLP and GMP guidelines. Our contract analytical services are tailored to the individual requirements of our customers.
- Batch control analysis
- Development of new methods
- Validation and transfer of existing methods
- Analytical reports
- Stability testing
Other services
EU GMP audits
- Audits of manufacturers and distributors
EU batch release
- Our own Qualified Persons provide EU batch release services
Physical importation
- Physical importation services
Let’s discuss your requirements
Contact Meditrial