The Regulatory Affairs team provides comprehensive, end-to-end support across the entire product lifecycle, from clinical study development and initiation to the commercialization of pharmaceuticals, medical devices, dietary supplements, and cosmetic products. Known for its adaptability and responsiveness, the team ensures regulatory compliance while addressing the specific needs of each client.
Administrative Support includes company registration in Italy, management of fees owed to AIFA, SOP review for regulatory and scientific services, handling of deficiencies and sunset clauses, and consultancy on administrative and technical matters.
Scientific Services encompass congress management, review and submission of promotional materials, coordination of free sample requests, annual training on regulatory and scientific updates, and management of accreditation, tracking, and reporting of Medical Scientific Representatives.
Support for Italian Manufacturing Sites covers regulatory assistance during GMP audits, periodic assessment of regulatory changes, and submission of variations and administrative applications.
Medicinal Product Lifecycle Management (LCM) services include regulatory strategy, preparation and review of required documentation (including M3), creation of eCTD sequences, and management of variations from pre-submission to approval for nationally registered, MRP-DCP, and centralized products. The team also handles corporate database updates (e.g., Veeva), CCDS control, artwork management, printed materials oversight, dossier gap analysis, and continuous monitoring of regulatory updates from AIFA, MINSAL, EMA, and FDA.
By combining technical expertise, meticulous attention to detail, and a client-focused approach, the team ensures that all regulatory, administrative, and scientific obligations are met efficiently and accurately, helping clients navigate complex regulatory landscapes with confidence.
The fee will be calculated based on the estimated number of days required to provide the services, at an average of €500 per day.
The Regulatory Affairs team operates across multiple regulatory, administrative, and scientific domains within the life sciences sector, including pharmaceuticals, medical devices, dietary supplements, and cosmetics. While the team offers comprehensive support throughout the product lifecycle, each engagement is subject to a preliminary assessment to verify the applicability of its expertise to the specific regulatory context and client needs and request. Support is provided in accordance with applicable regulations and based on the information available at the time of the assignment.
Access to Infrastructure & R&D Support
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