We work as your partner,
not supplier.
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
Logistica
Commissioning & Qualification
Logistica
Maintenance & Engineering
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.
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:
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
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FAQs
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.
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.
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.
