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DirectoryBusiness & Technical ServicesManagement ConsultingBaselDiapharm Switzerland GmbH
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Diapharm Switzerland GmbH

Summary

About the company

The company provides services in the field of regulation and approval of pharmaceuticals, medical devices, dietary supplements, and cosmetics. The core activities include: Regulatory Strategy and Regulatory Affairs for pharmaceuticals and medical devices, Development and Licensing of pharmaceuticals and medical devices, Pharmacovigilance and Quality Management (GxP) for pharmaceuticals and medical devices, Approval and Registration of pharmaceuticals and medical devices, Consulting and Audits in the field of GMP (Good Manufacturing Practice), Responsibility for OTC licenses (Over-the-Counter licenses), Services for dietary supplements and cosmetics, including labeling, claims, and notification.

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Offering

Products & services

Industry:Management Consulting
✓ Offered12
Consulting
Consulting for pharma and life sciences companies, focusing on understanding markets, designing innovations and establishing processes; converting regulatory hurdles into strategic solutions.
Regulatory Affairs for medicinal products
Marketing authorisation and registration, eCTD dossiers, environmental risk assessments, readability tests, Rx-to-OTC switch and due diligence for medicinal products.
Assumption of responsibility for medicinal products
Assumption of marketing authorisation holder, Step Plan Officer, Information Officer and Qualified Person functions, as well as batch certification within the scope of manufacturing and import authorisation.
Quality management (GxP) for medicinal products
GMP consulting and audits, implementation and maintenance of quality management systems, risk management and FMEA, authorisation under pharmaceutical law, as well as API audits.
Development & licensing of medicinal products
Development of OTC medicinal products for industry as well as brokering suitable existing authorisations and licences.
Scientific information for medicinal products
Regulatory review and compliance of pack labelling, SmPC, package leaflet and promotional material in the medicinal product dossier.
Pharmacovigilance
Pharmacovigilance systems, risk management plans and PSURs for medicinal product safety, as well as ongoing support with safety and reporting obligations.
Assumption of responsibility for medical devices
Assumption of the role of responsible manufacturer within the meaning of the MDR and IVDR, as well as regulatory responsibility for medical devices and in vitro diagnostics.
Medical devices: Clinical evaluation and conformity assessment
Clinical evaluation, performance evaluation for IVD, conformity assessment and CE marking for placing medical devices on the market.
Maintenance for medical devices
Monitoring and maintaining the conformity of medical devices and in vitro diagnostics throughout the entire product life cycle.
Combination products
Regulatory support for products at the interface of medicinal product and medical device regulations, with coordinated assessment of both requirements.
Dietary supplements
Advice on classification questions, portfolio strategy, marketability, labelling and health claims for dietary supplements, FSMP and special foods.
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Location

Hochbergerstrasse 70
4057 Basel

At a glance

Legal form
Limited Liability Company
UID
CHE-326.849.079
Founded
2021 · 5 years
Last commercial register change
September 23, 2021
Employees
1 to 10

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