MEDICINAL PRODUCTS
- Management of all types of registration procedures (NP, MRP, DCP, CP, Repeat Use...)
- Preparation of registration strategy
- Preparation and actualization of registration documentation for all types of applications
- Due diligence registrační dokumentace
- Due diligence of registration documentation
- Conversion of registration documentation into eCTD format
- Communication with the registration authority
- Readability User Test
- Preparation of SPC, PIL texts, labels on packaging and mock-ups
- Request to change of dispensing method from Rx to OTC
- Preparation of documentation, including management of procedures for extensions, changes in registration, MAHa transfers, etc.
- ERA preparation
- Evaluation of marginal products
- Monitoring of legislative requirements
COSMETICS, FOOD SUPPLEMENTS, FOOD FOR SPECIAL NUTRITION
- Notification/Registration
- Professional guidance in the preparation of documentation for chemical/microbiological analysis
- Preparation and examination of texts of packaging materials and translations
- Insurance of certificates for individual types of products
- Graphical processing of artworks
MEDICAL RESOURCES
- Registration/ notification
- Preparation of the texts of packaging materials, including translations and graphical processing
- Translations of manuals
- Monitoring of legislative requirements
