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Regulatory Affairs
- Strategies
on GMP
production
from
clinical
to
market
supply
of
APIs
- Strategies
on Investigational New Drug applications (IND) and Biologics Licence Applications (BLA) in US and Europe, including CMC
documentation
- Update on new regulatory developments and consequences
- Time
and
cost
effective
strategies
on
regulatory
requirements
(e. g.
change
procedures,
transfers)
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