Regulatory Inspections and Compliance Guidance
- Comply with the compliance requirements of FDA 21 CFR 211.34 for consultants.
- Expert guidance on FDA 483s, OAIs, Warning Letters, Recalls, EMA regulations, and other regulatory non-conformance remediations.
- Batch record evaluations, protocol development and review, and compliance issue resolution.
- Review and remediate data integrity issues identified during internal audits or regulatory inspections.
- Address cross-contamination risks during regulatory inspections.
- Navigate complex regulatory landscapes with confidence.
EU/UK Qualified Person Batch Review and Certification
- Provide EU/UK Qualified Person batch review and certification to ensure products meet stringent regulatory requirements before release.
- Uphold data integrity in batch certification processes.
- Ensure cross-contamination control in batch certification.
Chartered Scientist and Chartered Chemist Review and Certification
- Risk assessments.
- Critical investigations.
- Critical processes.
- Compliance responses.
CGMP and Responsible Sourcing Audits
- Specialize in CGMP and Responsible Sourcing audits (Ethical Sourcing, Social Accountability, and Supplier Sustainability) to ensure compliance with regulatory standards, ethical practices, and sustainability.
- Emphasize data integrity, cross-contamination prevention, and nitrosamine contamination controls in our audits.
- Provide regulatory inspection preparation, including ISO 13485 and SA8000 compliance.
Pharmaceutical Responsible Person (RP) Services
- Provide RP services to distributors, wholesalers, manufacturers, and logistic providers.
- Ensure adherence to GDP, MHRA, EMA, FDA, and WHO guidelines.
- Manage supplier qualification, risk assessments, and product safety.
- Oversee product recalls and adverse event reporting.
Quality Assurance and Regulatory Compliance
- Develop and maintain robust quality management systems to ensure your products meet the highest standards.
- Conduct comprehensive GMP and GDP audits to guarantee compliance.
- Align your operations with international standards and regulations.
- Maintain impeccable data integrity throughout all quality processes.
- Implement stringent measures to prevent cross-contamination and ensure product safety.
Supplier Quality Management
- Manage global supplier quality, including onboarding, qualification, and performance management.
- Conduct GMP compliance and quality due diligence audits worldwide.
- Ensure data integrity and Nitrosamine contamination control measures in supplier audits.
Sterile Manufacturing and New Product Introduction
- Leverage our expertise in sterile manufacturing processes, facility design, validation, and new product introduction.
- Host successful audits and inspections.
- Ensure data integrity and implement cross-contamination control in sterile manufacturing.
Project Management and Process Improvement
- Exemplary project management abilities, overseeing multiple projects simultaneously.
- Drive continuous improvement initiatives, including root cause analysis, risk analysis, and process optimization.
- Maintain data integrity and address cross-contamination risks in process improvement initiatives.
Training and Mentoring
- Mentor and train industry professionals by sharing knowledge and expertise.
- Foster the next generation of pharmaceutical leaders.
- Promote data integrity and educate on cross-contamination control to uphold industry best practices.
- Provide training on responsible sourcing requirements and best practices.
- Conduct cGMP, GDP, and other tailored training programs.