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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.
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