Our experts in Regulatory Affairs deal with all authorization procedures: from clinical development to marketing of medicines, medical devices, AFMS food supplements and cosmetic products, managing authorization processes with the main Italian regulatory authorities (AIFA, Ministry of Health), European (EMA) and non-European (FDA and local authorities).
WITH NO BOUNDARIES
Experts in regulatory affairs for clinical trials and life science product
REGULATORY AFFAIRS IN CLINICAL STUDIES
We facilitate the regulatory procedures in a quick and complete way
As a CRO we can guarantee a complete support in the management and supervision of all the necessary regulatory activities in clinical studies.
As a Certified CRO we are able to support you during all the phases of the clinical studies and to manage and monitor all the regulatory procedures for conducting the study in compliance with the current regulations. Our experts are the contact point between national and international study centers, the ethics committees and the sponsor, and they manage the correct information between all the players involved in the regulatory process, for the entire duration of the clinical research.
We prepare and revision the study documentation for submission to regulatory bodies and we offer consultancy on regulatory strategies, time and cost planning, in order to guarantee the study efficiency and efficacy. Our experts manage the following activities:
- Dossier preparation for clinical studies authorization requests to the Competent Authority and for the opinion of Ethics Committees
- Document preparation and adjustment following the current legislation
- Authorization activities management of clinical studies
- Notifications of substantial and non-substantial amendments management
- Contacts preparation with center for experimental research
- Final data publication on dedicated websites management (EudraCT and Clinicaltrial.gov)
PRE AND POST-MARKETING REGULATORY AFFAIRS
We take care of the product lifecycle management
We assist each pharmaceutical company in all the regulatory procedures for new registrations and product lifecycle management.
Our JSB consultants in Regulatory Affairs manage all the activities of lifecycle management, including the post-marketing phase, verifying that the documentation for submission to competent authorities is completed and in compliance with current regulations. Our expertise in this sector allows us to provide all the necessary regulatory services:
- Regulatory submission and technical data evaluation and preparation (chemistry/production, preclinical, clinical) of all the regulatory procedures – National (EU and extra EU), Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP), Centralised Procedure (CP) management
- Regulatory Dossier preparation and maintenance
- Monthly specific planning
- Technical support on regulations
- Product Information Management
- eCTD compilation
JSB has also a vigilance unit with an experienced staff in the field of medicines for human (pharmacovigilance) medical devices (materiovigilance) cosmetics (cosmetovigilance) and phytotherapeutic products (fitovigilance).
REGULATORY AFFAIRS FOR MEDICAL DEVICES
We deal withall the necessary phases for the EC marking of the product
Complete assistance in planning and designing all the activities for medical devices marketing.
Medical devices are crucial in the diagnosis, prevention, monitoring and treatment of diseases, representing a fundamental contribution to citizens’ health. Our experience in this field allows us to give regulatory and procedural support to companies that produce and marketing medical devices, working in compliance with European Regulation (Regulation UE 2017/745). Starting from a first phase of consulting services, we follow all the steps of the CE marking, up to the commercialization and post-commercialization. In particular, we give support in:
- Classification of MD
- Identification of regulatory obligations for Manufacturers, Importers and Distributors of medical devices
- Preparation and revision of Technical File
- Certification process management for obtaining the EC mark by a Notified Body
- Notification management to health authorities in EU countries
- Notification of medical devices in the database/directory of the Ministry of Health
- Preparation of advertising and, if necessary, authorization request
REGULATORY AFFAIRS FOR COSMETIC PRODUCTS, FOOD SUPPLEMENTS AND AFMS
In compliance with industry standards and regulations
We follow the customer companies in the production, registration and marketing of cosmetic products, food supplements and food for special medical purposes (AFMS), allowing them to be in compliance with the respective regulations that regulate go-to-market and use.
We assist companies in the drafting of labels and informative material, cosmetovigilance, request for Free Sale Certificates (FSC), assistance in the evaluation of individual ingredients and drafting of technical data sheets. We prepare, in relation to the commercial sector of interest, the preparation of specific documents “REACH dossiers, PIF, CLP notifications, NIH notifications, etc.” or documentation proving the exemption to the obligation requested. On behalf of the company, we interface directly with the competent bodies present throughout Italy (MdS, ASL) and Europe.
We support companies in the implementation of technical-scientific promotion with the drafting of specialized information documentation both in the commercial promotion of supplements and cosmetics
ADVERTISING REGULATORY AFFAIRS
Medical and cosmetics product advertising
We take care of the preparation and launch of medical-scientific promotional contents to ensure the regulatory compliance.
For the Pharma and Life Science sectors we assist in outsourcing manufacturing companies and advertising agencies in the strategic preparation and review of marketing and communication activities, in compliance with current legislation and in accordance with the product class to be promoted.
For companies advertising medicines and medical devices is a very important aspect and depending on the type of products marketed, can be conveyed to different targets:
- Public for SOP and OTC drugs; Medical devices; Food supplements/AFMS and Cosmetics
- Health professionals for prescription drugs
In JSB, pharmaceutical marketing embraces the regulatory field: we can support the customer starting from the elaboration of a marketing strategy up to the sending of promotional material to the competent regulatory authorities, also offering the service of Head of the Scientific Service for:
- Ensure adequate training for scientific informants in accordance with the regulations;
- Interfacing with the authority on behalf of the holding;
- Offer strategic support during the implementation of the promotion campaign.