FDA/GMP Regulatory Compliance / Quality Systems / GXP

• Regulatory Agencies Registrations: We are US Agents
• Systems Based Approach Compliance: Quality, Laboratory Controls, Packaging and Labeling, Production, Materials, Facilities & Equipment
• Post Approval Changes and Regulatory Compliance Assessments
• Regulatory Enforcement Corrective Actions / cGMP Plans to meet 483's, Warning Letters, Consent Decree commitments
• Pre-approval Inspection Readiness (PAI)
• Quality Systems Compliance Audits:Investigations / CAPA; Change Control; Annual Product Reviews (APR's), Complaints, SOP's & Quality Policies; Calibration, Preventive Maintenance, Validation, Laboratory Systems, Audits
• Risk Analysis
• The QA Pyramid Compliance
• cGMP, GXP  Auditing / Compliance / Training
• Regulatory Agencies Regulations Compliance Assessments:
  • US: FDA, EMEA, DEA, CBER, CDER
  • PR: DSPR, ASSMCA
  • Canada: Health Canada
  • European: EMEA, MHRA
  • Middle East: GCC
  • China: SFDA
  • Latin America: ANVISA, COFEPRIS
  • Other International
• Pharmaceopeial: USP/NF; EP, JP
• ICH: International Conference Harmonization Guidelines Compliance
• NDA/ANDA/CMC Filings Compliance Audits
• Stability Protocols and Stability Programs
• Packaging and Labeling Regulations
• Complaint Reports and Investigations / CAPA
• Regulatory Filings Requirements (US, International) during Products Transfer or Post Approval Changes
• Evaluation/Assessment of Validation status and Validation/Qualification Documents Assessment
• Standard Operating procedures Development and /or translations
• Benchmarking
• Gap Analysis
• Pre-FDA submission reviews
• Controlled Substances Security programs
• Product and Packaging Component Specifications
• Change Control Procedures
• Annual Product Reviews / Annual Product Reports
• Batch Records Reviews / Revision / Verification for compliance to filings (NDA / ANDA / CMC Section)
• GAP Analysis, Remediation Plans and Implementation
• Regulatory Consulting
• Third Party Audits and Vendor Qualification
  • Vendor Audits
  • Software
  • Equipment Manufacturers
  • API's
  • Raw Materials Supplies

Our skilled and senior level professionals hold the Education required and the regulatory experience necessary, to ensure compliance with all regulatory agencies.