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Capability

Regulatory Affairs

Suppliers
28
States & provinces
15
Countries
3

28 regulatory affairs suppliers across 15 states and provinces in 3 countries. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

G & L SCIENTIFIC INC

MADISON, NJ

G&L Scientific is an Integrated Product Development and Market Access platform serving the pharmaceutical, biopharmaceutical, and biotechnology industries. Established in 1998, it provides specialist Regulatory Affairs and Quality Assurance services across 100+ global markets, spanning drug and clinical development, regulatory submissions, product approval, market access, quality and compliance, and business transformation. It offers a flexible Functional Service Provider (FSP) model and won the Queen's Award for Enterprise 2022 and King's Award for Ente

Advisory, Transformation and Designclinical developmentCMC servicescommercializationFull Service OutsourcingFunctional Service Provider modelMarket Accessquality assuranceStaff augmentation

Helsinn is a global pharmaceutical company focused on supportive care, oncology and dermato-oncology, building, manufacturing, launching and commercializing products to improve the quality of life for patients with cancer and chronic diseases. Headquartered in Lugano, Switzerland, it has direct commercial operations in the U.S., manufacturing operations in Ireland, offices in China and partners enabling a commercial presence in 90 countries. Founded in 1976, it is a third-generation family-owned company.

commercializationdevelopmentdirect salesin-licensinglife-cycle developmentmanufacturingout-licensingsupply chain

ICON is a clinical research organisation providing outsourced clinical development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. It offers clinical, consulting and commercial services across sectors including biotech, government and public health, medical devices and pharmaceuticals, and has contributed to over 60 FDA/EMA approved therapies in oncology CGT in the last 5 years.

analytical method development and validationclinical developmentclinical trialsformulation developmentglobal depot and distributionmedical imagingpackaging and labellingsmall-batch manufacturingstability testingtranslation and linguistic validation

Knight Vision Global Solutions, LLC (KVGS) is a specialized consultancy delivering services across four pillars: Investigations, Physical Security, and Protection; Legal, Litigating, and Regulatory Affairs; Information Security and Cyber Security; and Payment Operations, Growth Transformation, and Tech Implementation. The company emphasizes collaboration, customization, and long-term partnerships, with consultants located across the United States and a physical presence in the US and Panama.

Admission seeking interviewsAML/BSA complianceChange management and process transformationconflict resolutionCybersecurity consultancyeCommerce fraud and identity theft investigationsestate planningFraud detection, prevention, and mitigationInformation security compliance guidance and auditsInsurance investigationsinternal investigationsinvestigationslitigation supportOrganizational governancePayment compliance guidance and auditsPhysical security and protectionprocess automationRisk management and risk assessmentsSecure software engineering

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