Our mission is to provide the kind of support that will give your studies the best chance to succeed. Our help should result in:
-Proper management of your clinical trial studies
-Avoiding delays or even rejections
-Time savings
-Minimising of costs and efforts.
Clinical trials can be applied for and conducted in many ways depending on the phase, purpose and size of the study, the type of drug substance and drug product, drug formulation, use of placebo and more.
Since the requirements on the regulatory documentation vary significantly from phase 0 to phase IV, it is key to correctly interpret relevant guidelines and regulatory framework to perform safe, efficient, and high-quality studies and deliver valid test results and documentation.
Among the contributing factors of a successful clinical study are:
Arex Advisor can author, manage and coordinate the regulatory documentation for IMPDs/INDs for global applications in all phases of the clinical trials, covering Type I and II changes, the IMPD, Investigator’s Brochure and more. We can also support regulatory strategic support for submissions throughout the whole drug product life cycle management.
Our consultants have extensive experience from the application process not only from the industry’s point of view, but also as former employees at the European Medicines Agency and the Swedish Medical Products Agency.
Scientific advice support
Medical writing
PIPs
Orphan Product Support
Erik Hedner
Arex Advisor AB
Contact us
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.