Regulatory Services

Lyomark offers a variety of regulatory services to the pharmaceutical industry.

Aside from the provision of dossiers on Lyomark products and filing for marketing authorisation on this basis, we can also offer the following services:

Product Quality Review (PQR)
Lyomark can compile the PQR for the periods requested. Alternatively, the raw data can be provided for your own compilation of the PQR.

Database queries
At the required intervals, Lyomark can submit routine queries to relevant databases.

Periodic Safety Update Report (PSUR)
On request, Lyomark can compile the PSUR for the requested periods in a format suitable for submission. Company data can also be incorporated as required.

Please feel free to contact us!