Sidney
Smith, the Company Principal
Sidney Smith
brings over 33 years experience in both government regulatory
and pharmaceutical manufacturing environments to the Company.
As a senior executive in a generic company with global operations,
he was responsible for the planning and carrying out of laboratory
studies directed to regulatory filings in the United States, Canada,
and other countries. He has directed the formulation development
for over 50 drug entities, and also was responsible for all new
API sourcing and supplier evaluation and liaison.
Reflecting the competitive and legal nature of the U.S. generic
pharmaceutical environment, Sidney Smith gained experience in
dealing with patent issues relating to generic pharmaceutical
development. He has also participated in court challenges relating
to "paragraph IV" declarations
In his practice as a consultant, Sidney Smith works with and advises;
- Finished
pharmaceutical manufacturers
- Drug substance
and synthesis intermediate manufacturers
- Specialized
and strategic pharmaceutical intelligence and marketing companies
- Law firms
