Marketing Authorisation (MA)Submission of dossiers for MA applications (National, Decentralised and Mutual Recognition Procedures).Activities required for local compliance following Centralised Procedures.Co-ordination of MA Applications to ensure timely approvals.Consultancy services concerning local regulatory requirements. Product Maintenance MA maintenance and constant product update according to requirements:VariationsRenewalsPost-approval notificationsSunset ClauseLocal contact point Regulatory & Medical DocumentsNon-clinical and clinical literature overviews.Investigator’s Brochure (IB) sections.Regulatory review of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling.Regulatory review of packaging material.Regulatory review of promotional material. Medical Affairs and Pharmacovigilance Educational Material local language review and submission to Health Authorities. Direct Healtcare Professional Communication; preparation, review, submission to Health Authorities and circulation to local Healthcare Professionals. Scientific and medical HCP communications or visits as partial fulfillment of local Medical Affairs or Medical Science Liaison (MSL) service. Medical DevicesLocal notifications of Medical Devices.Local contact point to Health Authorities. Contact us for any inquiries concerning our services or to discuss about specific requirements that we can be of assistance.