"Coming together is(Henry Ford)
|Development of new therapeutic entities can be a complex process requiring a sound strategy and a detailed project plan. These are essential for progression of a compound through the different phases of preclinical and clinical testing in a timely and cost-effective manner.
Drug development begins with the synthesis of a molecule and the formulation of the drug product, making CMC a critical element to any drug development program.
Use our experience in pharmaceutical drug development and related regulatory affair issues to facilitate a fast and high quality development process. We are offering effective strategic and operational consultancy considering your project as a whole, not as a step by step process. With an unbiased view for inherent project risks we help you to develop solutions.
Our regulatory affairs consulting service empowers you to maintain control of your pathway towards submission and stay ahead of any compliance risks. With practical interpretation, we help you understand how guidelines around the world apply to you.
The value of your product will be enhanced with seamless compliance to GMP and GDP requirements ensured by our profound pharmaceutical quality assurance consulting.
Dr. Julia Eva Diederichs