IT ALL STARTS WITH ONE CALL

• GMP (Good Manufacturing Practices) Certification preparation, US FDA QSR (cGMP), US FDA 21 CFR 820, 210 and 211, US FDA Quality Systems Inspection Technique (QSIT);
• Canadian regulations for cosmetic and medical device industries;
• Establish facility startup business or operations with analytical business, management and quality planning;
• Implementation / Certification Regulatory Compliance;
• Internal audits, supplier audits, and assessments;
• Corporate strategy implementation;
• Training: GMP, Quality System Regulation, Design Control, Process Validation, Compliance programs, MDSAP, MDD, IVDR, ISO 13485, ISO 9001 and ISO 14971;
• Establish supplier/vendor chain management programs;
• Due diligence evaluations for acquisition and investment;
• ISO 9000, ISO 13485 and MDD quality systems implementation;
• Setup Quality / QC Compliance programs;
• Conduct regulatory client/supplier audits;
• Facility registration - domestic and international;
• Setup domestic and international operational manufacturing and quality assurance;
• Consent Decree and “483” Remediation;
• FDA Inspection 483 and Warning Letter, responses and corrective action plans;
• Provide assistance on detained imports by obtaining products’ clearance through U.S. Customs and FDA at the time of entry;
• Product recalls assistance;
• cGMP Compliance/ Mock FDA inspections / mock Pre-Approval Audit and Readiness Assessments;
• Quality Systems, GDP, and systems-based implementation and auditing;
• Audit results evaluations, interpretations, and corrective action plans;
• Medical Devices Product (CE mark) Technical Files Compilation, submission / registration, with a successful product launch to market;
• Subject Matter Expert (small & large manufacturer);
• Due diligence evaluations for acquisition and investment;
• Device Submission 510(k);
• Project management, process engineering, and reengineering;
• Writing manuals, policies, and procedures;
• Failure Mode and Effects Analysis (FMEA); Risk Management per ISO 14971;
• Design of Experiments (DOE);
• CAPA program implementation;
• Equipment and sterilization validations;
• Process development and validation master planning;
• R&D Portfolio Analysis / Independent reviewer.

FOR COSMETIC PRODUCT PREPARATION:

• Product Information File (PIF) assembly and Compilation, submission/registration, with a successful product launch to market in the EU;
• Cosmetic testing;
• Preparation for Cosmetic Safety Assessments;
• Cosmetics ingredient profiles;
• Cosmetic Product Safety Assessment;
• Regulatory Compliance Support; And Product Labelling Review and Support.