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.

ICH guidelines

GCP

EMA

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