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US GMP COMPLIANCE AND AUDITS

Donawa Lifescience Consulting (DLC) can assist you in the development and implementation of GMPs to meet US requirements.

We have an experienced ex-FDA field investigator available to help pharmaceutical companies develop, implement, and maintain their processes and procedures in compliance with US GMPs. We also have specialists in manufacturing process validation and computer system compliance, including meeting FDA Part 11 electronic records requirements.

Our team can assist with: 

• Developing systems to meet GMP requirements
• Help with process and computer system validation
• Assistance with SOP development
• Reviewing existing systems to ensure compliance with relevant regulations and guidance
• Conducting gap analyses
• Conducting mock audits or inspections
• Assistance with corrective actions from mock audits or actual inspections
• Help in responding to inspection reports and warning letters

Please contact us to see how we may be able to help.