Solutions
we provide include:
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Technology and product development, commercialization and manufacturing.
•
Technology transfer from R&D into manufacturing or across other
organizational or intracompany interfaces.
•
Strategic and tactical planning and implementation associated with new products.
• CMC sections for IND's, NDA's, DMF’s and ANDA's reviewed and
written.
• Expert Reports for foreign applications written and reviewed.
• FDA pre-approval inspection preparation.
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CGMP assessments made for laboratories, pharmaceutical and API development and
manufacturing activities. Necessary
CGMP upgrading recommended.
•
Management of contract development or manufacturing firms, including selection
and ongoing relationships. Evaluations conducted in the following areas.
- Technical staff
- Regulatory
- Quality
- Environmental
- Equipment
- Infrastructure
•
Cleaning and process validation guidance, including protocol design and
critique. Equipment IQ/OQ protocol
design and critique.
• Covers both the active pharmaceutical ingredient and final dose form.
• Engineering evaluations of process, utilities and facilities.