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Regulatory Compliance and Quality Systems

Kinexum provides experienced professionals for a range of services in outsourcing regulatory and quality assurance requirements.

Global Regulatory Compliance Capabilities

• Develop Clinical, Non-Clinical, and CMC sections for INDs / NDAs / MAAs
• SOP Development - GCP / GMP / DEA
• NDA Conformance Guide Development
• GCP Auditing
• Investigator site auditing
• IRB auditing
• Investigation of potential issues
• Training
• cGMP training and QA training, and GCP training (SOPs, Auditing, Site preparedness, FDA inspections [Regulatory Agency])
• cGMP Auditing
• Investigator Sites
• Analytical Labs
• Drug Product and Bulk Drug Substance Manufacturing
• Preparedness for Pre PAI or Post PAI audits
• Vendor Qualification
• Drug Product Packaging and Labeling and Clinical Packaging and Labeling
• SOP development (GCP, cGMP and DEA)
• Validation Development
• Facility, Equipment, and Systems
• Resolve Regulatory Issues
• Develop site 483 corrective action plan/Warning Letter issues/Compliance issues
• Product Development Strategy (CMC)

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