ASPHANET
Pharmacovigilance & Regulatory Affairs European Local Contact Network
Enhance your Pharmacovigilance and Regulatory Affairs capabilities in EU thanks to ASPHANET.
We are introducing our new service, AsphaNET, a 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
A network of qualified partners that allows ASPHALION to provide pharmacovigilance services throughout Europe.
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
A network of qualified partners that allows ASPHALION to provide RA services throughout Europe.
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
