Our GxP services in several Industries

Biotech

• GMP & GCP Auditing and Compliance Services​

• Regulatory Inspection Readiness Services​

• Quality Oversight and Compliance Support​​

• QMS Development & Optimization​

• GMP & GCP Consulting Services​

• External Manufacturing (CMO/CDMO) Oversight

Pharmaceutical

• QMS Development & Optimization​

• GMP Compliance and Auditing​

• GLP Compliance and Laboratory Services​

• GDP Compliance and Supply Chain Oversight​

• Regulatory Compliance Consulting​

• SOP Development & Review​

• Deviation and CAPA Management

Radiopharmaceutical

• Regulatory Strategy, Compliance, and Inspection Readiness​

• GMP Facility Design, Qualification, and Environmental Monitoring​

• Process Development, Manufacturing

• ​​Quality Management System (QMS) Development and Internal Auditing​​

• Vendor Qualification, Supply Chain Management, and Cold Chain Compliance

Medical Devices

• Internal Audits (ISO 13485 / FDA QSR)​

• Supplier and Vendor Audits​

• Mock FDA / Notified Body Audits​

• Compliance Audits for EU MDR / IVDR Transition​

• Regulatory Compliance Audits (Global)​

• QMS Implementation and Enhancement​

• FDA Inspection Readiness Programs

Dietary Supplements

• GMP Compliance Audits​

• Supplier and Vendor Audits​

• Internal Audits and GAP Analysis​

• FDA Mock Audits​

• Quality System Audits​

• Labeling and Claims Audits​

• GMP Implementation and SOP Development​

• Regulatory Compliance Support