CMC Regulatory Affairs

•    Write modular CMC dossiers for NCEs and combination products during all stages of pharmaceutical development, marketing, and post-approval support.
•    Identify critical issues and write the background package for FDA end of Phase 2, pre-NDA, and other meetings with health authorities.
•    Train your R&D, pharmaceutical manufacturing, and pharmaceutical regulatory staffs to conduct and manage effective and successful meetings with regulatory agencies. 
•    Work with your project teams to develop a Quality Target Product Profile (QTPP) that will provide strategic direction to your CMC regulatory development programs.
•    Collaborate with your R&D, manufacturing, and project teams to develop persuasive and effective comparability protocols to facilitate long-range post approval change strategies.
•    Conduct CMC due diligence with your national and international business partners.

 

Developing World (ROW) Regulatory Affairs

•    Provide guidance on the development of comprehensive registration strategies for medicines in Latin America and the Caribbean, SE and Central Asia, sub-Saharan Africa, Oceania, India, and other areas of the developing world.
•    Work with your pharmaceutical regulatory affairs team, local agents, distributors, and translators to customize and write safety, efficacy, labeling, and CMC modules to meet local registration requirements.
•    Provide insightful training that will help guide your staff to conduct and manage regulatory affairs in the highly diverse environments of the developing world.
•    Write WHO Pre-qualification dossiers for qualified products, and obtain GMP, CPP, Apostilles, and import certificates as required by local regulations.
 

"A satisfied customer is the best business strategy of all."

Micheal Lebouef

"Success often comes to those who have the aptitude to see way down the road."

Laing Burns, jr.