REGULATORY AFFAIRS
Health care regulation around the world is constantly evolving. We offer the most effective regulatory and pharmacovigilance services in the area of medicinal products, cosmetics, veterinary products, medical devices and food supplement.
REGULATORY KNOWLEDGE AND SUPPORT
To minimize the risks of regulatory burdens
Strategic regulatory assesment of the projects
Identify the critical RA points
Set up the risk plans
Suggest the RA plans
Execute the RA activities
Leveraging on international cooperation and interoperability by coordinating the diverse global aspects and requirements
REGISTRATIONS, NOTIFICATIONS, AUTHORISATIONS
To meet your specific needs in the whole product lifecycle
We offer full registration and notification services in area of medicinal products, medical devices, cosmetics and food supplements. Based on long-term experience our global team of experts has the knowledge and ability to help you during short consultation or deliver tailor-made solutions of the whole process.
Dossier Compilation and pre-submission evaluation
Compilation eCTD files
Regulatory Affairs support in Europe, USA, CEE
Marketing Authorization Holder service
VIGILANCE AND PHARMACOVIGILANCE
Safety first! We will keep you secure...
Our Qualified Persons and all Pharmacovigilance team are ready to meet you and solve all legislative requirements required.
We offer our own validated safety database, electronic reporting, preparing Standard Operating Procedures and agreements about safety data exchange, assistance or preparing of risk management plans (RMPs), responding to regulatory enquiries, helping with evaluation of benefit and risk and assisting in responding to safety concerns.
Surveillance of the safety of goods on the market also applies to other groups of products in the field of medical devices, food supplements and cosmetics.
GET A SOLUTION
Tell us what you need, we will tell you what to do...