Recent Achievements

           Design and implementation of numerous successful drug development plans:

           ○ Recombinant drug from initiation of toxicology to EU & US submissions in 23 months.

Europe :
National & Centralised Procedures and Registrations
National & CPMP Scientific Advice
Establishment of new Guidelines with BWP & EMEA

US :
CDER & CBER pre-IND and pre-NDA meetings
IND and NDA filings
Senior staff experienced in FDA registrations

Drafting new Regulatory Guidance with EMEA:

Note for Guidance on Comparability of Medicinal Products containing Biotechnology-derived Proteins as Active Substance,
Points to Consider on the Manufacture and Quality Control of Human Somatic Cell Therapy Medicinal Products,
Points to Consider on the Use of Transgenic Plants in the Manufacture of Biological Medicinal Products for Human Use.

           Definition and execution of optimal regulatory strategies to achieve marketing authorization:

           ○ First successful EU registration of a fully human monoclonal antibody.

           ○ First successful registration of a multisource recombinant product in the EU .