Consultancy on regulations and strategy for developing new products or treatments, for translational studies, in accordance with EMEA and FDA guidelines
Consultancy on medicinal product registration strategies
Consultancy in the area of medical devices
Consultancy in the area of cosmetic products
Consultancy in the area of food and nutrional products
Applications for marketing authorisation
Variation, renewal and transfers of marketing authorisation licence-holders
Post-marketing monitoring (national MRP and centralised procedures)
Meetings with authorities to monitor processes
SPCs, patient information leaflets, labelling
Expert reports
Investigator’s brochures
Readability studies of patient information leaflets
Applications for prices and reimbursement
Pharmacotherapeutic studies
Applications for authorisation for clinical trials (ethnic committees and regulatory authorities)
Preparation and validation of IMP
Customs clearance of experimental medicines
Import and export of experimental medicines and study materials
Authorisations for special use
Translations: Summaries of product characteristics, Patient information leaflets, Labelling of medicinal products for sale, Labelling of medicinal products for clinical trials, Patient information and informed consent forms, Protocols and synopses, Case report forms (CRFs), Investigator brochures, Scientific articles, Other technical documents
