Regulatory Filings

We have prepared a wide spectrum of regulatory documents that include:

• NDAs, supplements, and annual reports
• INDs and amendments
• FDA meeting requests and briefing documents
• Field Alerts, warning letter & 483 responses
• Orphan Drug Applications

Product Development

We have participated in a wide range of product development programs from lead optimization through NDA filing and approval. We have participated in organizations by:

• Identifying optimal IND enabling project plans
• Managing virtual product development
• Identifying drug product dosage forms and drug supply strategy
• Overseeing formulation and analytical development

Technical Business Support

We have supported a number of business activities that include:

• Technical due diligence support of in-license and out-license of pharmaceutical products
• Technical support of M&A activities
• Business development support for programs with a significant technical component.

Process design, validation and troubleshooting

We have led efforts to comply with the FDA’s increasingly difficult requirements on process development and control. Our expertise positions us to lead investigations into trouble shooting, out of trend and out of specification results.

• CQAs & CPPs and implementing proper control strategy
• Lyophilization and other process failures
• OOS and OOT investigations
• Stability programs and failures
• Validation of processes, methods and equipment

Strategic and Portfolio Evaluation

• Development of business plans and investor presentations
• Solidifying product development strategies
• Evaluation of portfolio options for development
• Participate as product development team leaders & members
• Identify non-dilutive grant funding

Pharmaceutical Supply Chain

• cGMP supply chain strategy
• cGMP manufacturing plans for development and commercial products
• Confirming compliance with cGMPs
• CMO and CRO evaluation and selection
• Inspection responses to 483 and warning letters