If your company is sponsoring clinical trials, have you considered multi-regional trials and what you may need to do to ensure that your data is credible, reproducible and appropriate for use in targeted patient populations across the globe?
If you are a manufacturer and are sourcing raw materials from foreign locations, are you aware of new strategies FDA is considering for securing the integrity of the nation’s drug supply?
Our FDA consultants and FDA regulatory scientists are extremely knowledgeable about the implications of clinical development programs conducted both domestically and internationally, and can help sponsors and manufacturers with ensuring FDA compliance while obtaining meaningful results.
We also assist sponsors, manufacturers, distributors and importers, by embracing the globalization of the pharmaceutical industry while providing strategies for ensuring that all material and products coming into the US market meet acceptable quality standards to support their commercialization.
Whether a US-based or foreign firm, sponsoring clinical or bioequivalence studies, or manufacturing API or finished dosage forms, we specialize in global product development and approval strategies and can help your company develop compliant strategies for:
NDAs, sNDAs, 505(b)(2)s:
• GCP compliance and the conduct of both domestic and multi-regional development strategies for efficient trial design
• Pre-IND and End-of-Phase II preparatory meetings with FDA and establishing consultations with foreign regulatory authorities
• Preparation/manufacturing of trial materials
• ANDAs
• Product development strategies for the US, Latin America, China, Korea, and other Pacific-rim locations
• GCP compliance for the conduct of bioequivalence studies
• Evaluation of appropriate reference listed drug (RLD) in your development pipeline
Manufacturing:
• cGMP compliance and audits
• Personnel Training programs
• Product eligibility for purchase under the WHO prequalification program and China’s Essential Medicines List
• Serialization strategies to comply with international packaging and labeling requirements
• Preparing for Commercial Launch
• Registration of facilities and products (NDC listing)
• Advertising and Promotion support
• REMS management
Cynthia Ipach – Drug & Medical Devices Consultant
Compliance Insight
497 Circle Freeway Drive, Suite 230, Cincinnati, Ohio, 45246