CMC REGULATORY AFFAIRS

Karlton CMC Consulting is a pharmaceutical regulatory affairs consultancy specializing in CMC and developing world regulatory affairs.  Our strategic perspective and extensive hands-on skills enable us to bring a global and dynamic perspective to your CMC and developing world regulatory submissions. 

CMC is one of the most highly regulated areas of regulatory affairs.  Almost half of all ICH guidances on Safety, Efficacy, and Quality are now devoted to CMC - not accounting for the numerous local CMC guidances in effect at the national and regional levels in both the developed and emerging worlds.

CMC information encompass a very significant part of your dossier's proprietary information, and it also forms the core of most marketing applications in the developing and emerging world. 

In the US, the review of CMC post-approval change supplements has historically been a formidable challenge for FDA resulting in initiatives such as the  Pharmaceutical cGMPS for the 21st Century.

As a result of the inherent complexities of CMC, your company's CMC regulatory affairs functions must be well coordinated with your  manufacturing and QA change control system.  The coordination of global change control with CMC regulatory requirements is an essential component of your regulatory compliance.

Developing and implementing a strategy for post approval changes once your product is approved and launched requires a highly collaborative effort among all of the members of your supply chain. 

Your goal will be to launch with the best possible "product image." 

DEVELOPING WORLD REGULATORY AFFAIRS

Registration of medicines in the emerging world is the next great frontier in pharmaceutical regulatory affairs.  The emerging world encompasses well over 100 countries with unique cultures, languages, legal systems, business customs, and regulatory requirements. 

An in-depth knowledge of these diverse attributes and their impact in regulatory affairs is an essential component of  a global pharmaceutical development and registration strategy.   

Karlton CMC Consulting can provide the "hands-on" experience necessary to achieve success is these complex and highly variable pharmaceutical and regulatory environments.  We will guide you in the preparation of complete regulatory marketing applications in sub-Saharan Africa, Latin America and the Caribbean, India, SE and Central Asia, Oceania, and other “rest of world” (ROW) emerging world regions. We will also work with distributors, agents, translators, and national health authorities, including WHO, to ensure that your marketing applications meets local and regional regulatory affairs requirements.

Karlton CMC Consulting offers sophisticated training to help your staff understand the complexities of the emerging world regulatory environments.