GLOBAL
Pharmacovigilance & Regulatory Affairs European Local Contact Network
Enhance your Pharmacovigilance and Regulatory Affairs capabilities in EU thanks to Asphalion’s Local Contact Network.
Our network of qualified partners that allows us to provide pharmacovigilance and regulatory affairs services throughout Europe.
These are some of the several advantatges of having a solid EU network:
- Simplicity and Time optimization: Single point of RA and LPPVs management by Asphalion.
- Trust: Reliable regulatory affairs and PV experts in all EU markets.
- Local presence throughout Europe: knowledge of local regulation and native language.
- Close relationship with local health authorities.
- Improved quality and homogenization in all deliverables and outcome
Pharmacovigilance
Regulatory Affairs
Pharmacovigilance
Navigating Local Pharmacovigilance across global territories
Our value
- Single point management of LPPVs throughout Europe.
- Qualified and validated pharmacovigilance partners.
- Strong knowledge of local PV legislation, local requirements and know-how.
- Standardized procedure for local literature searches and ICSR management.
Advantage of a good network
The importance of the partner network for the company:
- Trust and advice
- Proximity
- Specialization
- Agility
Local Pharmacovigilance Services
- Cell phone availability for Local Authorities.
- Direct interaction with local competent authorities on regulatory matters and pharmacovigilance.
- Set-up of local pharmacovigilance requirements.
- Local contact person for authorities’ inspections.
- Periodic Agency Website screening to maintain updated CLIENT knowledge of PV local requirements.
- Collaboration with CLIENT on audits and inspections.
Contact person in case of urgent safety issues from Local Authorities.
Local Medical information.
Regulatory Affairs
Navigating Local Regulatory Affairs across global territories
Our value
- Single point of RA management throughout Europe
- Reliable RA partners
- Sound knowledge of local regulation.
- Native speakers for labelling and artworks management
- Local contact with access to national Health Authorities
Advantage of a good network
- Trust: Reliable regulatory affairs experts in all EU markets
- Local presence throughout Europe: knowledge of local regulation
- Knowledge of all EU languages
- Close relationship with health authorities
- Time optimization and simplicity: Single point management of all your European registrations
- General oversight improves the final outcome
Regulatory Affairs Services
- National phases of DCPs and MRPs for initial MAA and variations (product information translations, mock-ups review, follow up with authorities until approval)
- Management of national authorities’ portals and databases
- Mandatory activities before launch
- Annual mandatory activities for maintenance of MA
- Local variations and MA transfers
- Renewal of National MA
- Update and request of price and reimbursement for new and generic products
- Promotional materials (submission to national competent authority, support in material preparation according to national requirements, proof-reading, regulatory and medical validation)
- Continuous update on changes of local requirements (Regulatory Intelligence)
- CTIS Local Support
