- Reviewing and Aligning Responses to Regulatory Authorities (USFDA)
- We help you craft accurate, comprehensive responses to FDA inquiries and ensure that your responses meet regulatory expectations.
- Understanding FDA Action Alerts
- We provide clear explanations of FDA action alerts such as Official Action Indicated (OAI) and Voluntary Action Indicated (VAI) classifications. We guide you through what to expect and how to address these alerts effectively.
- Aligning with FDA Expectations
- Our consultants work with you to align your processes with FDA guidelines and expectations, ensuring compliance with FDA procedures and internal structure requirements.
- Collaborative Remediation
- We partner with your team to resolve FDA-identified issues and implement sustainable solutions that will protect your business from future concerns.
- FDA Meeting Preparation and Assistance
- We support you in preparing for FDA meetings, ensuring that all necessary documentation and responses are ready for discussion.
- Reviewing and Tracking CAPA Responses
- Our experts will assist you in reviewing Corrective and Preventive Actions (CAPA), ensuring effective implementation and tracking of responses to avoid repeat issues.
- General GxP Guidance
- For quality-related queries, our experts are available to provide trusted guidance on Good Manufacturing Practices (GxP), Good Clinical Practices (GCP), and other regulatory requirements.
