regulatory-affairs-clinical-studies-and-pharma-products

PRODUCTS
WITH NO BOUNDARIES

REGULATORY AFFAIRS

regulatory-affairs-clinical-studies-and-pharma-products

PRODUCTS
WITH NO
BOUNDARIES

REGULATORY AFFAIRS

Regulatory Affairs

Experts in regulatory affairs for clinical trials and life science product

Our experts in Regulatory Affairs take care of all the authorization procedures: starting from the clinical development to marketing of drugs, medical devices, food supplements and cosmetics, managing all the authorization processes with the main Italian regulatory authorities (AIFA, MDS) and European (EMA).

REGULATORY AFFAIRS IN CLINICAL STUDIES

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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

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We take care of the product lifecycle management

We assist each pharmaceutical company in all the regulatory procedures for the 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 (chemistry/production, preclinical, clinical) of all the regulatory procedures – National, 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).

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REGULATORY AFFAIRS FOR MEDICAL DEVICES

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All the necessary phases for the CE 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 DM
  • Identification of regulatory obligations for Manufacturers, Importers and Distributors of medical devices
  • Preparation and revision of Technical File
  • Certification process management for obtaining the CE 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
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ADVERTISING REGULATORY AFFAIRS

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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 Sciences sectors, we assist in outsourcing companies and advertising agencies in the preparation and review of marketing and communication activities, in compliance with the current regulation and with the product class to promote (drugs, medical devices, cosmetics, food supplements). Our consulting activity starts from an accurate regulatory analysis and check of the advertising material or scientific information provided, and we can also support you in the application preparation and presentation to regulatory authority, to comply with legal obligations. Our support considerably reduces the risk of spreading non-compliant advertising messages, to avoid heavy penalties.

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