PhV post-authorisation
All pharmacovigilance activities needed to be performed in order to obtain Marketing Authorisation are necessary, however, it is worth noting that these are just the initial steps of the Pharmacovigilance activities that must be performed in the product’s life cycle. What is more, many post-authorisation actions have to be performed by MAH within strict deadlines, which are often very short. Fortunately, we can help with all of that here at SciencePharma – please contact us to discuss the best way we can assist you.
Our services include among others:
- ICSR management and reporting to the EU (Eudravigilance reporting) and non-EU Agencies,
- Signal management
- Cooperation with Local Points from the EU and non-EU countries
- Local pharmacovigilance representative
- Global and local literature monitoring
- PSUR and Addendum to Clinical Overview development.
Our Pharmacovigilance system is ready to get your company included in it. We have broad experience in cooperation with different EU and non-EU agencies and have knowledge of non-EU GVP requirements.
By choosing SciencePharma as your Partner in pharmacovigilance, you can be sure that you choose an experienced, trusted partner who will guide you along already known paths. Thanks to this, you can count on timely reporting provided even to the most remote destinations of the world. Similarly, when it comes to the preparation of documentation such as RMP or PSURs – the PhV world has no secrets from us.