Regulatory Affairs

Regulatory Affairs

At Consortium Clinical Research, the Regulatory affairs personnel ensure appropriate licensing, marketing and legal compliance of pharmaceutical and medical products of our Sponsors. We combine knowledge of scientific, legal and business issues, which enable products that are developed, manufactured or distributed by a wide range of companies to meet the required legislation. We advise on; and co-ordinate the approval and registration of pharmaceuticals, therapeutic devices and other products.

Our Regulatory affairs personnel serve as the crucial link between our sponsors’ organization, its products and the regulatory authorities.

Our lists of activities include (but are not limited to):

Ensuring that a company's products comply with the regulations;

Keeping abreast of domestic and international legislations, guidelines and customer practices;

Collecting and collating a wide range of related information;

Keeping up to date with a company's product range;

Developing and writing clear logic and explanations for new product licences and licence renewals;

Understanding and evaluating complex regulatory information;

Working with specialist, expert review committees & relevant resources;

Writing clear, accessible product labels and patient information leaflets;

Planning and developing product trials;

Interpreting trial data;

Advising scientists and manufacturers on regulatory requirements;

Resolving complex issues as they arise;

Preparing and coordinating documentation;

Managing documents involved with the development of new products;

Maintaining quality systems;

Managing regulatory inspections;

Reviewing company practices and providing advice on changes to systems;

Liaising with, and making presentations to, regulatory authorities;

Submitting licence and clinical trials applications to authorities within deadlines;

Negotiating with regulatory authorities for marketing authorization;

Specifying storage, labeling and packaging requirements.