Regulatory submissions in Europe and in the USA for drug, nutrition, medical device.
ISO 9001: 2008 Certification for al activities: set-up, conduct, folow-up of clinical trials and data analysis.
21 CFR part 11
More than 20 years of experience in Clinical Research
Compliance to national and international guidelines
A clear and eficient process
Various and up-to-date training of the staf
Broad experience in various therapeutic fields: Oncology, Pneumology, Endocrinology, CNS, Cardiovascular, Nutrition, Medical device, Infectious disease, Dermatology, Ophthalmology
Experienced and stable team of CRAs and project managers
A board of specialists
Respect of timelines
Advantages of working with us
Regulatory and guidelines expertise