DRUGS & BIOLOGICS

Consulting services include:

• Provide insight in the FDA’s procedures, practices, policies and regulations
• Review and assist in the preparation of INDs, NDAs, ANDAs, BLAs and DMFs as well as annual, semiannual and other reports submitted to FDA
• Review and assist with Over-The-Counter (OTC) drugs, such as drug product application, prescription to OTC switch, labeling etc.
• Review Standard Operating Procedures (SOPs), failure investigation reports, and third-party audit reports
• Assist in formulating a response to FDA pertaining to FDA-483s, Warning Letters, Application Integrity Policy Letters, recalls, and similar other regulatory communications from the agency
• Assist in drafting Corrective Action Plans monitoring progress and accomplishment
• Provide guidance and advice during acquisition of new companies or products, outsourcing manufacturing or other activities. Conduct Due Diligence audits
• Provide proactive enforcement guidance as well as post-enforcement recommendations (seizure, injunction, and consent decree negotiations)
• Training