TMC Pharma Services is experienced in all types of regulatory submissions
We have extensive experience of producing submissions to authorities, both nationally (local competent authorities within and beyond the EU) and centrally (EMEA).
Orphan and niche drug developmentRegulatory activities
• Clinical trial applications (CTAs)
We can prepare and submit applications for any country, within or beyond the EU. We can also create and review investigational medicinal product dossiers (IMPDs)
• Orphan drug designations (ODDs)
We have written and submitted numerous successful ODD applications
• Marketing authorisation approval dossiers (MAAs)
Either whole dossiers or specialist elements.
• European CTD overviews and CTD summaries
We produce CTD summaries and overviews for clinical, non-clinical and chemistry/pharmacy parts of the dossier, using external experts as needed during the process.
• Scientific advice procedures (EMEA or national authorities)
We prepare briefing packages and participate at authority meetings, EMEA, FDA etc
• Pre-approval sales authorisations for niche products, orphan drugs and other special situations
We have extensive experience of regulatory processes for compassionate/named patient use.
Other related services that we offer include:
• Management of extraordinary regulatory requirements, e.g. in response to Article 31 (formerly Article 12) procedures
• Acting as Marketing Authorisation Holder (MAH) for products in transition of ownership ensuring that a product's marketing authorisation is not lost while partnering activities are under way
• Marketing authorisation variations
• Pharmacovigilance submissions
- EudraVigilance and other submissions, both pre- and post-approval
- SUSARs, PSURs and ASURs including medical review and RP/QP services
• Provision of Legal Representative for clinical trials
Required in the EU by companies that do not have a European office.