At SCF, we take a strategic approach to regulatory activities — achieving goals on schedule and through the most suitable and effective, product-specific processes.
From strategy to life-cycle management
Medicinal products
From eCTD to Marketing Authorization
SCF’s expertise in pharmaceutical regulations and regulatory processes is rooted in years of experience and continually strengthened through constant updates, ensuring we stay ahead in a rapidly evolving landscape
SCF always encourages early dialogue with regulatory authorities, building tailor-made projects from scientific advice management through to obtaining authorizations, by maintaining relationships with regulatory agencies at both European and national level, with the aim of creating constructive dialogue.
SCF’s role is to support companies from dossier preparation to managing the procedures required to obtain and maintain Marketing Authorization (MA), always ensuring compliance with applicable regulations.
This is accomplished through a collaborative, team-based approach, enabling the eCTD submissions in compliance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). We also provide comprehensive life-cycle management of medicinal products, covering variations, Power of Attorney (PoA), printed materials, labelling, delivering expertise and precision at every stage.
Medical Devices and IVD
From technical documentation to CE marking
SCF assists companies that manufacture, market, MD and IVD throughout every step of the CE marking process and in ensuring ongoing compliance thereafter.
Our specialized team manages the complete device lifecycle: from regulatory affairs through Italian market access.
At SCF, achieving CE marking is a collaborative effort involving manufacturers, suppliers, and Notified Bodies. We work closely with manufacturers to define the most effective regulatory and market access strategy, preparing the technical dossier according to MDR, and continue our support throughout the post-market phase by preparing key documents such as the PMS Plan, PMCF Plan, and PSUR. Our approach ensures continuous vigilance and surveillance of the device, always in full compliance with applicable regulations.
Our services address every key regulatory needs, from gap analysis and device classification to risk assessment and labeling compliance. We support clinical evaluations, preparing Biological Evaluation Plans (BEP) and Reports, Summary of Safety and Clinical Performance (SSCPs), and conducting usability assessments in line with MDR requirements.
In addition, we assist with advertising authorizations, registration in Italian and European databases, regulatory due diligence, and provide a dedicated helpdesk — delivering comprehensive, end-to-end support throughout the entire life cycle of your medical devices.
Food supplements and Cosmetics
Food supplements are an important resource that contributes to individual wellbeing, widely used across all age groups. In addition to food supplements, the current regulatory framework includes a range of specific foods that must meet certain composition and labelling requirements: Foods for Specific Groups (FSG), namely foods intended for specific population groups with particular nutritional needs.
SCF supports companies in the sector navigate regulatory requirements and comply with the guidelines issued by the Italian Ministry of Health, supporting them through every step of the notification process, including:
- Feasibility studies and technical-scientific consultancy for food supplements and related products
- Label evaluation, notification process, and registration as an OSA (Food Supplement Operator)
- Authorization process for Novel Foods
- Development of promotional materials
Cosmetics are a widely used product category governed by Regulation (EC) No 1223/2009, covering good manufacturing practices, product and packaging composition, safety assessment, animal testing, market authorization requirements, and reporting of adverse effects.
SCF supports companies in navigating the preparatory steps for centralized European notification, including:
- Feasibility studies
- Label preparation and evaluation
- Drafting and/or reviewing the Product Information File (PIF)
- Requests for Certificates of Free Sale
- Development of promotional materials