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. Our combined knowledge of scientific, legal, and business issues, 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 related products.
Our Regulatory affairs personnel serve as the crucial link between our sponsors’ organization, their products and the regulatory authorities.
Our list 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
Preparing clear and logical explanations for new product licenses and license renewals
Understanding and evaluating complex regulatory information
Working with specialists and expert review committees
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 license and clinical trials applications to authorities within deadlines
Negotiating with regulatory authorities for marketing authorization
Specifying storage, labelling, and packaging requirements