We work as your partner,
not supplier.

WE ARE regulatory business experts FOR CLINICAL STUDIES AND life science products

Adaptability and reactivity: by choosing our Regulatory Affairs team, our clients will benefit of a multidisciplinary support on all lifecycle management, from the development and the launch of a clinical trial to the marketing of drugs, medical devices, food supplements and cosmetic products.

Clinical Research

Line Activation

Regulatory Approvals

Manufacturing

Distribution

Regulatory Affairs and Pharmacovigilance

Quality Assurance

AN organized TEAM FOR EVERY NEED

Thanks to the multidisciplinary nature of our team, we are able to respond to every kind of need in the regulatory field, providing support on a global level. Our most experienced consultants, selected by knowledge, skills and seniority, will be aligned to your project’s features, forming a structured work team that will guarantee a continuously optimized service.

SERVICES AND SOLUTIONS

Un supporto continuativo su tutto il lifecycle management

Our support will cover the entire life cycle of the drug, from the clinical phase to the maintenance of the product on the market. We follow our clients with constant attention to compliance with the previously agreed deadlines and budgets. Also, thanks to the transversal skills of our team, we can provide support in:

Strategic Consulting
Authorization Applications, Variations and Renewals
Geographical Expansion
eCTD and Regulatory Procedures Management
Pharmacovigilance

Our support in drug development

Development

Marketing Authorization

Market Access

Maintenance

Study of development plans for clinical trials (submission of IMPDs and INDs and selection and management of third party suppliers)

Management of registration procedures and response documents: drafting of the CTD and electronic submission

Market access consultancy and strategies (study of early access programs, P&R management, preparation and negotiation of the dossier)

Management of changes, renewals, promotional materials, medical information and pharmacovigilance activities

FAQs

What are the possible types of consultancy in the Regulatory Affairs area?

JSB can assign a dedicated consultant to your company or create a support team based on different senioriteis, but the latter will be still led by an experienced consultant.

What are the benefits of having a support team and not a single consultant?

Each client will benefit from a team customized to fit their needs, with a Project Manager who will be the client’s primary interface. Thanks to this model, JSB is able to guarantee rapid responses, effective management of emergencies, as well as a continuous service 365 days a year, with flexibility to respond in case of work peaks.

Is your support limited to the Italian market or is it global?

JSB is structured with internal expertise able to provide global support. In countries where it is necessary, we have activated partnerships with local companies to guarantee our customers a worldwide service.

Our Blog

Regulatory Affairs: medicines registration in EAEU

Case Study

Geographic Expansion and Verification of Regulatory Requirements

Work with us

We are always on the lookout for new talent