Services

• Consulting and contract work in all areas of GXP quality and compliance, including at the leadership and strategic level, covering preclinical through commercial phases
• Interim leader for GMP/GLP and GCP Quality departments/functions and audit programs
• Global GXP auditing, risk assessment, and due diligence for CDMOs, CROs and Labs, including for-cause audits - experience in the US, Canada, EU, UK, Eastern Europe, Israel, India, China, Japan, and Singapore 
• Preparation for and hosting of GXP regulatory and health authority inspections at the Sponsor or at CMO/CRO/Clinical Sites, and hosting of Due Diligence audits 
• Mapping of GXP and other processes to support development of compliant and fit for scale Policies, SOPs, Work Instructions and Business Practices (Governing 
• Source Data verification for IND, NDA, MAA and other regulatory documents
• Technology Transfer for Biotech and Small Molecule API and Drug Product
• Process Validation and optimization for aseptic processes, including for cell therapy
• Decontamination/sterilization of isolators, GMP facilities, Labs and GMP equipment/components.
• Application of Quality Improvement tools and methods for process improvement, problem solving and root-cause analysis, for example: Kaizen, Leand Six-Sigma, FMEA, Ishikawa Diagrams, SIPOC, SPC, Process Mapping, Force Field Analysis, Prioritization using Relation Diagrams, etc. Implementing K-AI-Zen™ AI tools for facilitating rapid improvement initiatives.
• Organization development through establishment of Mentoring Programs, Change Management initiatives and performance coaching

For a list of recommendations and testimonials, please go to:  www.linkedin.com/in/amnoneylath and scroll down to the Recommendations section