Regulatory Compliance Support

Key Regulatory Compliance Services

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A. Compliance Audits & Gap Assessments

• Internal & supplier audits (GMP, ISO, FDA, EU MDR)

• Regulatory gap analysis (identify non-conformities)

• Corrective & Preventive Action (CAPA) plans

B. Certification & Licensing Support

• FDA 510(k), PMA, CE Marking (EU MDR/IVDR)

• ISO 9001, 13485, 27001 certification

• Environmental permits (EPA, REACH, RoHS)

C. Documentation & Submission Management

• Technical File/Dossier preparation (MDR, IVDR)

• eCTD (Electronic Common Technical Document) for pharmaceuticals

• Clinical Evaluation Reports (CERs) for medical devices

D. Quality Management System (QMS) Implementation

• GMP/GLP/GCP compliance

• SOP development & training

• Risk management (ISO 14971, ICH Q9)

E. Post-Market Surveillance & Vigilance

• Adverse event reporting (MDR, FDA MAUDE)

• Periodic Safety Update Reports (PSURs)

• Recall management & field corrective actions

F. Industry-Specific Compliance

• Pharma (FDA 21 CFR, EU GMP, ICH)

• Medical Devices (MDR, ISO 13485, FDA 21 CFR Part 820)

• Food & Beverage (FSMA, HACCP, FSSAI)

• Chemicals (REACH, TSCA, OSHA)

• Data Protection (GDPR, HIPAA, CCPA)

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