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- Assist with
product selection for product development
- Coach staff
in North American market requirements
- Evaluate
current manufacturing facilities
- Help meet
North American cGMP requirements
- Evaluate
written procedures and S.O.P needs
- Help set
specifications for drug substances
- Help address
patent issues
- Review DMFs
and open DMFs
- Assist with
technical packages
- Evaluate
in-house laboratory capability and capacity
- Assess stability
testing programs
- Assist with
responses to regulatory agencies
- Assist with
responses on customer technical issues
- Liaise directly
with representatives and customers on technical issues
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