Clients in Europe, US and the Middle East
One of our key focus points is to ensure that our clients always know that their submissions or projects are in safe hands. The close communication with our clients during the compilation of a submission or a software project, and ensuring a continuous match of expectations, are some of the key reasons to our success.
For list of references:
Please contact CEO and Founder, Steen Otto Rugaard, email@example.com or call +45 43 466 36
At PeC we have compiled eSubmissions in the following procedures:
EUROPE: Centralised Procedures (CP), Decentralised Procedures (DCP), Mutual Recognition Procedures (MRP) and National Procedures (NP), including submission types such as: Initial Marketing Authorisation Applications, Baselines (Reformat), Variations (including submission modes grouped and/or worksharing), Supplemental Information(s), PSURs, FUMs, SOs, Renewals, Transfers, Line-extensions, Article 61(3) and ASMF
CHINA: National Applications, New Active Substances (NA-NAS), New Galenic Form (Na-NGF), Initial Marketing Authorisation Application, Reformat, Variation requiring authorisation incl. scientific review.
USA: New Drug Applications (NDA), Biologic License Applications (BLA), Abbreviated New Drug Applications (ANDA), Investigational New drug Applications (IND), including submission types such as: Original Applications, Amendments, Resubmissions, Annual Reports, Other(s), Chemistry Manufacturing Controls Supplement, DMFs, Arbitrations and Withdrawals.
CANADA: New drug Application (NDA) and test application
RoW: Argentina, Italy, Mexico, Venezuela, Russia, Israel and Australia