Our dedicated team provides full lifecycle support regarding regulatory services.
We are the interface between the regulator and each partner's project team and the channel of communication with the regulator as the project progresses, ensuring that the project plan correctly anticipates what the regulator will require before approving the product.
We are responsible for obtaining approval for new pharmaceutical products and ensuring that this approval is maintained for as long as our business partner wishes to keep the product on the market.
We offer dedicated services in the field of industry regulation, in line with legislation. Thus, we are at the service of our partners with the following actions:
SOLUTIONS
Support and customized solutions for introducing and maintaining pharmaceutical and health care products on the Romanian market
AUTHORITIES
Trustworthy partnership in relation to competent authorities
PROJECTS
Trusted partners for any internal project or external collaboration in for proper management in accordance with industry legal provisions
REGULATIONS
Monitoring local regulations and supporting implementation of relevant legislative changes
SCIENCE
Scientific service dedicated to maintaining the correctness of packaging inscriptions and product characteristics as well as for any other needs
CONSULTANCY
Strategic advice on promotional, educational and any other business needs