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More Ways MEDVACON Can Help
Every situation below represents work we do every day across pharma, biotech, medical device, cell & gene therapy, and contract manufacturing.
cGMP Training
Our team needs cGMP training that actually changes how people work. Most compliance training is forgotten within a week because it is generic. MEDVACON builds and delivers cGMP training tied to your specific environment, your processes, and the gaps your team needs to close.
Project Management
We have a complex compliance initiative and need experienced project management. Compliance projects fail when they are managed like operational tasks. MEDVACON provides project management built specifically for the pace, documentation requirements, and regulatory stakes of life sciences work.
Technology Transfer
We are executing a technology transfer and need expert oversight. Technology transfers fail when knowledge gaps are discovered too late. MEDVACON manages the process to ensure the receiving site can consistently reproduce what the sending site built.
Qualification, Compliance, or Audit Support
Our laboratory operations need qualification, compliance, or audit support. Laboratories that are not properly qualified create downstream risk across every product they touch. MEDVACON assesses, qualifies, and remediates laboratory operations to the standard your products and regulators require.
CAPA or Deviation Management
We have a CAPA backlog or deviation management problem that is not resolving. An aging CAPA backlog is one of the first things FDA investigators look for. MEDVACON works through the backlog, identifies systemic root causes, and builds a deviation management process that stays current.
Suppliers and Contract Partners
We need to qualify or audit our suppliers and contract partners. A supply chain is only as compliant as its weakest link. MEDVACON designs and executes supplier qualification and audit programs that give you an accurate, defensible picture of every critical partner.
EU MDR or IVDR Compliance
We are a medical device company navigating EU MDR or IVDR compliance. EU MDR and IVDR requirements are more demanding than the directives they replaced, and the timelines are real. MEDVACON guides medical device companies through the technical documentation, QMS alignment, and notified body process.
Compliance Support
We are involved in an acquisition and need compliance due diligence support. Compliance liabilities discovered after a deal closes are expensive. MEDVACON assesses the quality and regulatory posture of acquisition targets, so you know exactly what you are buying before you commit.
Validation Support
We need validation support across processes, equipment, and cleaning. Validation gaps surface at the worst possible moments, during inspections, audits, and scale-up. MEDVACON designs and executes validation programs that are technically sound and built to withstand regulatory scrutiny.
We Need to Hire
We need to hire quality and compliance talent. Finding qualified people in quality, regulatory, and validation is genuinely difficult and a bad hire in these roles creates risk. MEDVACON places experienced professionals who can contribute from day one.
