DTA consulting is a consulting company who provides clients with a unique insight to the regulatory mindset and regulatory thinking. Regulatory expertise supports faster time to market in a cost efficient way. We have vast international expertise in regulatory affairs and clinical research within a number of therapeutic areas. Please click on “Services” to get more comprehensive information.
The company is founded and headed by M.Sc (Pharm) Dorrit Andersen, who has more than 30 years of experience in Regulatory Affairs, Clinical Research and Quality.
The mission of DTA Consulting is to provide high quality regulatory counselling and assistance to the development and commercial production of biological, drug, and device products. biotech industry and the pharmaceutical industry from discovery through clinical development.
Our core competencies:
· Vast experience in regulatory affairs requirements in USA, EU and Japan
· Evaluation of regulatory options
· Development strategies
· Interaction with regulatory agencies e.g. USA and Europe
· Regulatory support to biotech companies and other pharmaceutical companies
· Clinical development plans
· CMC documentation
· Regulatory strategies
· Preparation of regulatory documents
· Preparation and conduct of meetings with regulatory agencies
· Due diligence
· INDs and CTAs
· Marketing applications
· Project management