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DirectoryBusiness & Technical ServicesTechnical Consulting & EngineeringLuganoLEX Pharma Consulting SA
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LEX Pharma Consulting SA

Summary

About the company

The core activity of LEX Pharma Consulting SA is the provision of CMC (Chemistry Manufacturing Control) consulting services to the pharmaceutical industry. This includes, among other things: CMC regulatory consulting, technical transfer of production processes, due diligence reviews for product evaluation, support in defining GMP starting materials, process validation strategies, preparation of authorization applications, and identification of suitable Contract Manufacturing Organizations (CMOs) for the production of custom synthesis starting materials. The company offers these services to improve the efficiency and quality of production processes in the pharmaceutical industry and to ensure compliance with regulatory requirements.

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Technical Consulting & Engineering
✓ Offered9
CMC consulting
CMC support for the pharmaceutical industry, from early drug development through to post-approval changes; including CMC strategy, GMP starting materials, process control strategy and lifecycle management.
CMC Regulatory
Overall CMC filing strategy, GMP starting material definition, Prozesskontrollstrategie and Produkt-Lifecycle-Management from IND/CTA submission to technical Post-Approval changes and variations procedures.
Project management
Project management for CMC projects, including project plans, dashboards and periodic reporting; from drug discovery to resolving issues for marketed products.
CMO/S partner sourcing
Sourcing suitable CMO partners and supporting technology-transfer project management for CMC and manufacturing projects.
Dossier Module 3 Writing and/or Review
Creation or review of Dossier Module 3, taking into account country-specific requirements, in particular for EU, US, Japan, Brazil, Russia, Mexico, Australia, New Zealand and China.

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Location

Via Gaggini da Bissone 8
6900 Lugano

At a glance

Legal form
Corporation
UID
CHE-216.289.853
Founded
2021 · 5 years
Last commercial register change
September 24, 2021
Employees
1 to 10

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