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SME tailored solutions within Pharmacovigilance

Pharmacovigilance obligations are difficult to meet for small and medium-sized companies. For many it is simply not economically attractive to employ people with the relevant experience.

A-consult offers services specifically suited for small and medium-sized enterprises.


Electronic case handling
All Marketing Authorisation Holders (MAH's) are expected to report adverse drug reactions electronically. This requires special technical solutions. However, you do not have to learn all the technicalities. Our staff is trained users of Eudravigilance EVWEB and A-consult offers cost efficient solutions based on this system. Contact us to learn more about how we can assist with electronic case handling.

Database
Your cases can be archived in our validated pharmacovigilance database. The system server is secure, with appropriate back-up and disaster recovery programmes in place.

Data can be queried and extracted from the database for use in regular management reports, routine signal detection, periodic safety update reports or responses to enquiries from regulatory authorities.

Using the database has no setup price. The cost for using our database are based upon two charging elements:
  • Case entry
  • Creation of the first report of the case for reporting
Contact us for more information.


MedDRA license fee waiver
Small companies may be eligible to the MedDRA license fee waiver. We can advise you on the MedDRA license policy and help you to obtain your fee waiver.

A-consult also offers:
  • Registration of your company in Eudravigilance
  • Training
  • Counselling
  • Pharmacovigilance System Master File / DDPS
  • SOP writing
  • PV Agreement assistance
For further information, please do not hesitate to contact us.

A-consult a/s
Gladsaxevej 3821
DK-2860 Søborg
Denmark

Tel: +45 38330080
Fax: +45 38330280
a-consultata-consult.dk

 
 
Business units:
Let us bring you to a safe landing