Pre–Approval Regulatory Activities
TMC Pharma Services is experienced in all types of regulatory submissions
We have extensive experience of producing submissions to all major authorities worldwide. We cover North and South America, Europe (both centrally via EMA and individual competent authorities), major African countries, Australia, New Zealand, Japan, South Korea and beyond.
We have extensive experience of producing submissions to all major authorities worldwide. We cover North and South America, Europe (both centrally via EMA and individual competent authorities), major African countries, Australia, New Zealand, Japan, South Korea and beyond.
- Maintenance of licenses, marketing authorisation variations, such as changes in manufacturing, changes in Product labelling
- Acting as local Marketing Authorisation Holder (MAH) for products in transition of ownership ensuring that a product’s marketing authorisation is maintained while partnering/other activities are underway
- Provision of Qualified Person (QP) for batch release, site audits etc.
- Provision of Qualified Person for Pharmacovigilance (QPPV)
- Provision of Scientific / Medical service
- Pharmacovigilance document submissions
FDA, EudraVigilance and other territory submissions
SUSARs, PSURs / PBRERs and DSURs including medical review - Management of extraordinary regulatory requirements, e.g. in response to EU Article 31 procedures, product recalls etc.
