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.

Chemical and Microbiology Laboratory Support Commissioning, Qualification and Validation Computer Systems Validation EHS Services Engineering Services Equipment Rental Information Technology and Management Services  Placement, Staffing and Recruiting Process / Packaging Services Project Management Regulatory Compliance Risk Management Technical Documentation Technology Transfer Training / Seminars ~ Request for Information