Regulatory Affairs
Placet Research is able to provide regulatory consultancy services both in Europe and the USA.
These services include support in the design of regulatory strategy, the preparation, filing and maintenance of INDs, NDAs, MAAs, PMAs, and other registration documents in addition to regular contact with the regulatory authorities in Europe and the USA as well as site/CRO/vendor audit on the sponsors behalf.
Regulatory Affairs Services |
for Europe | for US |
• European Authorities Liaison
• Scientific advice meeting coordination
• Services supporting site/CRO/vendor audit on the sponsors behalf | • FDA Liaison
• assistance with IND submission and management
• Support for NDA submissions development (Pivotal CSR and Clinical Summary)
• Services supporting site/CRO/vendor audit on the sponsors behalf |