Regulatory Management

CEBIS Regulatory Management

Our objective is to facilitate the success of your business by streamlining the pharma regulatory process. CEBIS’s experienced regulatory consulting and compliance team has unmatched breadth and depth of knowledge regarding the FDA and EMA regulatory frameworks, and can assist you in achieving your business goals. Our regulatory consultants devise comprehensive strategies for your product, outlining a clear progression through all of the critical milestones necessary for a successful outcome. We can also assist you with your post-authorization regulatory pharma needs, such as the launch of your product, line extensions (LE), and variations, as well as maintaining the optimal regulatory status of your product throughout its lifecycle.

Regulatory management is the process of overseeing the implementation of standards and regulations established by government agencies for pharmaceutical companies, allowing a business to remain compliant with those regulations.
The scope of this type of management process frequently necessitates that regulatory managers understand the nature and application of all industry-specific regulations.

It is possible, with the assistance of CEBIS’s Regulatory managers, to develop internal policies and procedures that allow the company to remain compliant and avoid any type of government agency sanction.

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CEBIS Interantional

Romania- Helios Business Center (HBC),
47 Bd. Theodor Pallady,
Bucharest, Romania