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DirectoryBusiness & Technical ServicesManagement ConsultingHünenbergNCMA Consulting GmbH
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NCMA Consulting GmbH

Summary

About the company

The core activity of NCMA Consulting GmbH is the provision of nonclinical management and advisory services to the life science industry, particularly for companies in the pharmaceutical, biopharmaceutical and medical technology sectors. The services include: Interim management and consulting, Strategic consulting and planning, Regulatory consulting and regulatory documentation, Management and reporting of nonclinical studies, Nonclinical safety assessments, Nonclinical efficacy and safety assessments for the medical technology industry, Toxicological assessments of extractables and leachables, Chemical characterization. The company also offers services as a Swiss Representative (CH-REP). The core activity of the company focuses on supporting companies in the development of (bio)pharmaceutical products and medical technology products, particularly in the areas of nonclinical development, regulatory affairs and safety assessments.

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Management Consulting
Research & Development
✓ Offered8
Nonclinical Strategic Advice and interim management
Strategic support for nonclinical development programs, nonclinical development plans, budget and time estimates, regulatory strategy, gap analysis, as well as building and leading the nonclinical department.
Toxicology Consulting for the Biopharmaceutical Industry
Toxicology consulting for biopharma projects, nonclinical safety assessments, toxicological risk assessments of impurities, excipients, and extractables & leachables.
Nonclinical Study Management and Study Monitoring
Management and monitoring of nonclinical GLP and non-GLP studies, CRO selection and CRO management, tracking of milestones, data review, and issue management.
Regulatory Writing
Preparation of scientific advice briefing books, submission documents such as IND, IB, MAA and BLA, as well as responses to deficiency lists and justifications for waivers.
Toxicological Risk Assessments
Assessment of toxicological risks for impurities, excipients, extractables & leachables, as well as justification of PDE values.
Nonclinical Safety Assessments
Nonclinical safety assessments for biopharmaceutical drug candidates, including study planning, study monitoring, benefit-risk evaluations, and justifications for MRSD/FIH and dose escalation.
Due diligence and project evaluation
Due diligence, sparring partner for project evaluations, and support with expert assessments in the non-clinical setting.
Setup of a fit-for-purpose non-clinical SOP system
Development of a fit-for-purpose non-clinical SOP system for internal processes, documentation, and governance in the nonclinical area.
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Location

Bösch 80A
6331 Hünenberg

At a glance

Legal form
Limited Liability Company
UID
CHE-199.543.037
Founded
2021 · 5 years
Last commercial register change
November 18, 2021
Employees
1 to 10

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