Ensuring Safety and Efficacy of Healthcare Products
Medpoint is a valued partner helping clients maintain global compliance in quality, regulatory, and clinical affairs.
Quality Assurance
Maintain compliance with Medpoint's global supplier quality audit program or internal QMS gap assessment and remediation.
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Global Supplier Audit Program
Wherever your supply chain takes you, Medpoint has native language speaking consultants available to audit those critical suppliers. We offer the support 350 consultants strategically placed around the globe.
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Regulatory Affairs
The regulatory landscape is ever changing. Medpoint's team of former FDA and industry experts ensure compliant navigation of that landscape.
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Clinical Affairs
Crafting comprehensive clinical trial protocols and ensuring compliance via clinical site audits.
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Technical Consulting Services
Seasoned expertise in design controls, process engineering, sterilization, cleanroom validation, and technical due diligence.
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Talent Acquisition
Helping you find the most qualified candidate for your essential technical and management roles.
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Leading Expertise Serving Your Global Needs

Medpoint aims to be your chosen provider of exceptional consulting, auditing, and talent acquisition services both domestically and abroad. We bring leading experts with proven performance serving life sciences clients just like you. Medpoint consultants understand your manufacturing and process challenges because we’ve worked in the trenches learning and applying best practices. We don’t just dole out strategy…we deliver real solutions by working hand-in-hand with your team to achieve positive results. We appreciate your promise to deliver safe and effective healthcare products and will partner with you to help uphold that promise.

Whether you need assistance with global supplier audits, a QMS build, regulatory compliance, clinical site audits, training and more, Medpoint is here to help. Our team continues to support an extensive list of medical device, diagnostic, pharmaceutical, and biotechnology companies. Delivering comprehensive and impactful solutions is what we do best.

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Mission

Our Mission

Our goal at Medpoint is to meet our clients' needs efficiently and effectively. We take pride in our attentive approach, making sure we fully understand your needs and provide tailored solutions. You can count on our dedicated team for prompt responses and meticulous handling of every aspect of your project.

When you choose Medpoint as your consulting partner, you'll get unparalleled expertise and support. You can count on us to deliver exceptional results that drive your business forward. With our commitment to excellence and global network of experts, we're the preferred choice for your consulting needs.

Services
& Expertise

Medpoint professional services address a broad range of functional disciplines and challenges faced by life science companies. Our consultants bring seasoned technical expertise to deliver outstanding results. We put boots on the ground around the world at client and supplier sites, with engagements led by local experts most familiar with country-specific requirements. Medpoint’s competitive rates will provide cost-effective outcomes. Rest assured, our commitment to excellence never wavers. We’ll be your go-to resource.

Medpoint Quality Assurance services include annual global supplier audit programs, gap assessments and process remediation aligned with GMP and ISO standards.

Medpoint Regulatory Affairs experts can build your domestic or international regulatory strategy and carry clients through the entire submission process.

Medpoint Clinical Affairs services can support your clinical trial design and execution as well as provide clinical site and vendor audits.

Technical Consulting Services

Medpoint Technical Consulting provides specialized engineering and business expertise to address client challenges in operations, validation, training, due diligence, and more.

Talent Acquisition

Medpoint can help you find the right candidate for your Quality Assurance or Regulatory Affairs position with our extensive global network that match your needs.

Testimonials

We’re proud to have worked with many companies in the Medical Device, Biotechnology, and Pharmaceutical industries across the world. Here’s what some of our clients have to say about Medpoint services.

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We have had a positive experience working with Medpoint. The consultant has done a good job of helping us with our IQ/OQ/PQ process, and we were very happy that we were able to reconnect with him to train up new members of the team to allow consistency with our process. Medpoint also worked with us to try to identify someone to help with contact material compliance. Medpoint did a good job of identifying a resource and allowing us to chat with him to see if it felt like it would be a good fit. I will work with Medpoint again on future projects.
The team was very experienced, knowledgeable, and eager to get the job done. Medpoint completed the audit and provided an excellent audit report while on a very tight timeline which Medpoint should be commended for.

Principal Supplier Quality Engineer

Multinational Healthcare Services Company

I was very pleased to work with the Medpoint consultant. He had the right balance of technical knowledge and practical application skill. He also had great ideas around continuous improvement and how to manage things more effectively. Medpoint was very flexible and was very customer focused, helping us to get a work product that would really help us move forward.

Quality Assurance Director

US-based Biopharma Company

The consultants were a great pleasure to work with, the team respected and liked them. They took my pushback well in the few cases I did so. They were very eager to share their knowledge and to provide practical helpful suggestions for how to address gaps. I really appreciated their approach, professionalism, and delivery of just what we needed.

Our Recent News

 
    
 
Healthcare regulatory compliance plays a critical role in ensuring patient safety and quality. One of the tools used by regulatory authorities, namely the U.S. Food and Drug Administration (FDA), is the 483 warning letter. For&...

Deciphering the 483 Warning Letter: What Life Sciences Manufacturers Need to Know

Healthcare regulatory compliance plays a critical role in ensuring patient safety and quality. One of the tools used by regulatory authorities, namely the U.S. Food and Drug Administration (FDA), is the 483 warning letter. For&...
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When manufacturing medical devices or pharmaceuticals, ensuring the proper functioning and reliability of equipment, systems, and processes is crucial for producing quality healthcare products. This is where Installation Qualification (IQ), Operational Qualification (OQ), and Performance ...

Achieving the Three Pillars of Validation

When manufacturing medical devices or pharmaceuticals, ensuring the proper functioning and reliability of equipment, systems, and processes is crucial for producing quality healthcare products. This is where Installation Qualification (IQ), Operational Qualification (OQ), and Performance ...
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FDA’s Center for Drug Evaluation and Research (CDER) recently released a white paper, marking a significant step in pharmaceutical regulatory strategy with the establishment of a new Quality Management Maturity (QMM) program. QMM is ...

FDA’s Role in Quality Culture and Drug Availability

FDA’s Center for Drug Evaluation and Research (CDER) recently released a white paper, marking a significant step in pharmaceutical regulatory strategy with the establishment of a new Quality Management Maturity (QMM) program. QMM is ...
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Performance Metrics

Medpoint clients enjoy measurable success. Our dedicated efforts reduce risks, enhance efficiency, and develop robust strategies. These achievements have created significant cost savings and peace of mind. We’ve cultivated a more educated workforce for our clients through improved compliance and training. With sound project management and continuous improvement, we’ve helped our clients avoid unnecessary costs while delivering high-quality results on time. Our services have proven to be instrumental in driving success and ensuring positive outcomes for our clients.

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