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DirectoryBusiness & Technical ServicesTechnical Consulting & EngineeringSolothurnPCR Pharmaceutical Consultancy in Registration GmbH
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PCR Pharmaceutical Consultancy in Registration GmbH

Summary

About the company

The core activity of PCR Pharmaceutical Consultancy in Registration GmbH is consulting and providing services to pharmaceutical companies, particularly in the area of authorization documentation, Swissmedic applications, authority inquiries, maintenance of authorizations and reimbursement approvals.

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Offering

Products & services

Industry:Technical Consulting & Engineering
✓ Offered6
Swissmedic applications
Strategic consulting on regulatory requirements; preparation of Swissmedic applications for medicinal product authorisations, variations, renewals and dossiers in CTD, NTA, eDok and eCTD formats.
Reimbursement eligibility
Preparation of applications to BAG for obtaining and maintaining reimbursement eligibility, including new inclusion, APD, price increase and limitatio applications, as well as review of admission conditions.
Classification questions and borderline products
Handling of classification questions relating to medicinal products, medical devices, foodstuffs and cosmetics; assessment of marketability of medical devices, parapharmaceuticals, dietary supplements and FSMP.
Medical devices
Clarification of classification, Swissmedic notification for class 1 medical devices, assessment of marketability and reporting of incidents.
Regulatory authority contacts
Preparation and support of Scientific Advice meetings, representation vis-à-vis Swiss authorities and drafting of responses to authority requests.
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Location

St. Niklausstrasse 17
4500 Solothurn
Opening hours
Mon
08:30 - 17:00
Tue
08:30 - 17:00
Wed
08:30 - 17:00
Thu
08:30 - 17:00
Fri
08:30 - 17:00
Sat
Closed
Sun
Closed

At a glance

Legal form
Limited Liability Company
UID
CHE-112.951.612
Founded
2006 · 20 years
Last commercial register change
May 21, 2024
Employees
1 to 10

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