Medical writing
SERVICES
Medical writing
OUR SERVICES
Medical writing of regulatory documentation:
- Clinical Overview and Summary (all legal basis applications)
- Non-clinical Overview and Summary (all legal basis applications)
- Clinical Study Reports (CSRs), protocols, Investigators brochures (IBs), safety narratives
- Environmental Risk Assessment
- SmPC, PIL
- Bridging reports (readability)
- Writing of medical / pharmaceutical publications for journals
Medical writing in Pharmacovigilance:
- Company Core Data Sheet, Company Core Safety Information
- Periodic Safety Update Reports (PSUR / PBRER)
- Risk-benefit reports
- Signal detection
- Risk Management Plan (RMP)
- Medical assessment of adverse drug reactions
- Medical Enquiries
Biosimilar medicines
We offer guidance on comparability testing and preparation of non-clinical and clinical documentation, as required per Article 10(4) of Directive 2001/83/EC for the licensing of biosimilar medicinal products. Our experts can assist you in the registration phase, as well as in the post-marketing phase by managing the product’s pharmacovigilance.
For medical consultancy you need a lot of experience.
BILLEV PHARMA EAST
Do you have a question for us? Contact us and we will be happy to advise you and find the best solution for you together with you!
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Billev farmacija vzhod d.o.o.
Billev Pharma East Ltd.
2024 BILLEV PHARMA EAST
Operation title: BILLEV FARMACIJA VZHOD digitalizacija
Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund”. – Read more
Operation title: BILLEV FARMACIJA VZHOD digitalizacija Link to the European Cohesion Policy website: www.eu-skladi.si
“The investment is co-funded by the Republic of Slovenia and the European Union from the European Regional Development Fund.” – Read more
