Welcome To
Pharmaceutical Regulatory Affairs
Karlton CMC Consulting
Pharmaceutical CMC and Developing World Regulatory Affairs
Experience - Knowledge - Global Strategy
Karlton CMC Consulting
1008 Capuchino Avenue
Burlingame, CA 94010
United States
ph: (650) 430-8329
fax: (650) 393-5781
karltonc
Cultural sensitivity and awareness can make the difference between success or failure in the rapidly developing markets of the emerging world.
Regulatory Training -
The Developing WorldConducting business effectively in the cultural diversity of the developing and emerging world presents many unique challenges. Drawing upon our experience in more than 100 countries, we can train your pharmaceutical regulatory staff to understand these challenges. Your staff will gain a significant advantage in the market place through an astute understanding of cultural diversity and the role it plays in the pharmaceutical regulatory process.CMC Regulatory Strategy -
The Target Product ProfileWhat are the CMC requirements for INDs at each stage of pharmaceutical development? How do you build a "staged" development" of CMC information during clinical development that will culminate in a timely review of your NDA, ANDA, or MAA? These are important questions that require an "up-front" regulatory strategy beginning at the earliest phase of product development. Karlton CMC will design a Target Product Profile (TPP) that links your CMC product development with a long-range pharmaceutical regulatory strategy. It's never too early to define this essential component of the Quality by Design (QbD) initiative.
For additional information on how Karlton CMC Consulting can help you achieve success in these vital and highly specialized areas of pharmaceutical CMC regulatory affairs, please contact us today.
Karlton CMC Consulting
1008 Capuchino Avenue
Burlingame, CA 94010
United States
ph: (650) 430-8329
fax: (650) 393-5781
karltonc
