Services

• Consulting and contract work in all areas of GXP quality and compliance, including at the leadership and strategic level
• Interim leader for GMP/GLP and GCP Quality departments/functions and audit programs
• Global GXP auditing, risk assessment and due diligence for CMOs, CROs and Labs, including for-cause audits - experience in the US/Canada, EU, Eastern Europe, India, China and Singapore 
• Preparation for and hosting of GXP regulatory and health authority inspections at the Sponsor or at CMO/CRO/Clinical Sites
• Mapping of GXP and other processes to support development of Policies, SOPs, Work Instructions and Business Practices
• Source Data verifiation for IND, NDA, MAA and other regulatory documents
•  Technology Transfer for Biotech and Small Molecule API and Drug Product
• Process Development, validation and optimization for aseptic processes, including for cell therapy
• Decontamination/sterilization of isolators, GMP facilities, Labs and GMP equipment.
• Application of Lean-Six Sigma tools and methodologies for problem solving and root-cause analysis, for example: FMEA, Ishikawa Diagrams, SIPOC, SPC, Process Mapping, Force Field Analysis, Prioritization using Relation Diagrams, etc.
• 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