Quality & Compliance
Our Services:
From FDA and Client-driven compliance initiatives to quality assurance, inspection readiness and regulatory compliance, MEDVACON specializes in securing the integrity of your products, systems, and data.
Quality Systems Implementation
Regulatory agencies expect firms to have effective Quality Management Systems in place as part of demonstrating compliance with applicable regulations such as 21 CFR Part 211. Individual systems, including Document and Records Management, Change Management, Deviations and Investigations, CAPA, Training, and Auditing, become even more effective when the necessary connections between them are managed intentionally.
Warning Letter Remediation
Receiving a deficiency notice from a regulatory agency is serious. Responses must convey a keen understanding of both the issues and contributing factors, as well as communicating achievable and measurable end states. Successfully constructing the response and navigating the remediation process is critical to regaining the confidence of regulatory authorities.
Inspection Readiness
Inspection Readiness (IR) is the process of preparing for an inspection by a regulatory authority (such as FDA, EMA), or your client. Conducting an official review of documents, facilities, records, and any other resources related to the clinical trial is essential to any pharmaceutical company. This ensures employees’ understanding and application of policies, standards, and procedures.
CAPA, Deviation & Complaint Inv/Closeout
When manufacturing pharmaceutical products, unexpected events can occur, for instance during production, analysis, transport, storage or even during the qualification and/or calibration of equipment.
Medical Device Quality & Compliance
MEDVACON’s Medical Device Quality and Compliance experts help clients by applying a risk-based methodology. Our experienced team maximizes time and cost efficiencies through focused qualification. MEDVACON’s ability to apply industry trends and analyses to help define and implement best practices ensures rapid adaption to client project requirements.
Regulatory Compliance Consulting
Our Regulatory experts possess comprehensive knowledge of the Code of Federal Regulations and are prepared to assist you with your Regulatory Compliance Consulting needs. Our experience provides us with a unique understanding of the impact of federal regulations on your business operations.