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DirectoryBusiness & Technical ServicesManagement ConsultingOrbeInsideReg Sàrl
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InsideReg Sàrl

Summary

About the company

InsideReg provides consulting and support services to biotechnology companies in the development and authorization of innovative products, particularly in the field of pharmaceuticals. The core activity includes creating solutions for regulatory requirements, supporting clinical trials, preparing authorization applications, and accompanying products on their way to regulatory approval.

AI-generated
Offering

Products & services

Industry:Management Consulting
✓ Offered4
Regulatory Consultancy
Regulatory strategy, roadmaps, application legal basis, orphan drug designation, PRIME, SME status, PIP/PSP, submissions and lifecycle maintenance for medicinal products.
Non-clinical Consultancy
Non-clinical roadmaps, study design and protocols, gap analysis, scientific advice, due diligence, programme management, and Module 2 and 4 authoring.
Clinical Consultancy
Indication definition, clinical strategy and development plans, trial protocols, scientific advice, due diligence, PIP, and Module 2 and 5 authoring.
CMC Consultancy
CMC development plans, programme management, gap analysis, scientific advice, due diligence, IMPD/IND and Module 2/3 authoring, ATC/INN applications, and QP services.
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Location

Rue du Château 4
1350 Orbe

At a glance

Legal form
Limited Liability Company
UID
CHE-477.095.055
Founded
2018 · 8 years
Last commercial register change
June 22, 2018
Employees
1 to 10

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