Clinical Trials
Sponsors have an obligation to publish results in EudraCT. Asphalion offers services for the data entry of Clinical Trials results in EudraCT. Asphalion is also involved in the User Acceptance Testing of the new Clinical Trial Portal.
For Centralised Procedure submitted after 1 January 2015 the MAH has to submit redacted versions of the clinical information, which will be made public. Asphalion has experience with Transparency Policy compliance, including redactions and eCTD publishing during the Centralised Procedure.
eSubmission
Asphalion has wide experience with eSubmission for EU, FDA, Health Canada, Swissmedic including submissions by Gateway. eCTD is mandatory for ASMFs in the EU for Centralised Procedure Applications. eSubmission is mandatory for DMFs in Health Canada. Asphalion can support FDA projects such as: INDs, NDAs, ANDAs and BLAs. Asphalion has handled over 15 CP registrations. Asphalion is a certified provider for submission to FDA and Health Canada.
Global Procedure Management
Asphalion can take care of complete maintenance for you, which includes preparation of variations, translations, planning, submission, communication with HAs.
Asphalion has a dedicated US Agent for FDA submissions.
Asphalion has experience with the submission of Centralised and Decentralised Procedure to all EU countries (including biosimilars).
Asphalion supports the implementation of a validated Pharmacovigilance Database. Asphalion offers internal audits of Pharmacovigilance.
Asphalion provides local contact for Pharmacovigilance for Spain and Portugal.
Asphalion offers Medical Writing for PSURs, RMP and PSMF.
H2020
Asphalion can offer support for H2020 projects. Asphalion has experience in proposal preparation and the application process, with the first successful grant agreement in 2013 (iHIVARNA).
Asphalion has already 3 H2020 grants approved, providing support for the scientific assessment and Medical Writing of highly innovative therapies.
National Support in Spain
After submitting an application in Spain you have to fulfill mandatory requirements in the national portal such as splitting the SmPC and PIL and confirm administrative information after submitting maintenance procedures.
Asphalion can speed up the assessment through regular communication with the National Agency. Asphalion can provide you translated updates of local requirements.
