Quality and Compliance Services
From FDA and Client-driven quality initiatives to inspection readiness and regulatory compliance, MEDVACON specializes in securing the integrity of your quality systems and data.
What We Offer
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. Whether your firm is looking to implement more formal procedures or optimize well-established systems, the design, implementation, and ongoing management of these systems must focus equally on compliance, day-to-day ease of use, and traceability.
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. Remediation efforts often fail because either a rigorous evaluation of all root causes has not been performed, or a clear and manageable path to addressing them has not been well defined or executed. Successfully constructing the response and navigating the remediation process is critical to regaining the confidence of regulatory authorities.
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 to ensuring employees' understanding and application of policies, standards, and procedures.
Whatever your company’s role in the life science supply chain – whether it is as a supplier, manufacturer, or pharmaceutical, medical device, or biotech company – demonstrating Good Manufacturing Practice (GMP) is key to securing customer trust, building your reputation, and growing your business.
Pharmaceuticals, medical devices and biologics must be produced consistently and must be strictly controlled to meet both national and international standards applicable to intended use. Strict regulatory requirements must be met to satisfy those specified by US Food and Drug Administration (FDA) or UK Medicines and Healthcare Products Regulatory Authority (MHRA).
MEDVACON understands the challenges of virtual organizations that rely heavily on external partners to get things done, as well as those who manage complex supply chains. Our auditing and quality system experts can provide guidance that is tailored to your unique situation and needs.
MEDVACON delivers rigorous and comprehensive CAPA, Deviation & Complaint Investigation and Closeout services that are designed to help reduce the overall cost of compliance for Life Sciences organizations. 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.
MEDVACON provides a host of Regulatory Compliance consulting Services. 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.
In the private equity and trade buying space, regulatory change is the primary driver of market volatility. However, traditionally in M&A transactions, financial, legal and commercial considerations have taken precedence over regulatory considerations. Failure to perform robust regulatory / FDA Compliance due diligence is not an option in today’s regulatory environment and can lead to unknown liabilities materializing after the deal.
A technology transfer is what happens when a pharmaceutical company wants to change from an existing manufacturing site to a new manufacturing site. MEDVACON helps our clients by providing senior level pharmaceutical technology transfer experts to lead each technology transfer project.
MEDVACON provides assistance in lab projects in multiples areas such as: Lab audits/FDA inspection readiness services, facility and utility commissioning and qualification: evaluation of architectural and PID, GLP and GMP facility design and implementation, Instrument qualification and method validation, computer system validation (IQ,OQ,PG), and much more.
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. MEDVACONS ability to apply industry trends and analyses to help define and implement best practices ensures rapid adaption to client project requirements.