PROCESS DONE RIGHT.

Protocol Link is a global project management firm organized to provide comprehensive consulting services for FDA-regulated companies, including compliance management, quality systems, regulatory affairs, validation & qualification, business strategies, GMP documentation, and technical services.

Composed of senior, industry-experienced consultants and leaders in the scientific, technical, and business disciplines, Protocol Link offers the best of both quality and efficiency. It’s how we’ve been doing business since 1996. The right way.

WHO WE ARE

We have 26+ years of experience driving solutions and helping our clients achieve their business goals.

WHY WE DO IT.

Our team is passionate about the industries we serve and are dedicated to service excellence with each project.

COMPANY STATS

With more than 900 projects completed to date, representing engagements in more than 27 countries, Protocol Link continues to build a strong worldwide presence. Since our inception in January 1996, we have advised 100+ firms globally, ranging from start-ups to multi-national companies.

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Years of Experience
+
Satisfied Customers
+
Projects

OUR SERVICES

We offer an even balance of expertise and experience. Our consultants are hands-on, analytical, and strategic. We are driven by providing the best solutions to help our clients meet their business goals.

Compliance Management Services
Compliance Management

We keep up with the latest industry regulations and best practices so we can provide you with compliant solutions.
Quality Systems Services
Quality Systems

We develop policies, procedures, and practices to help you meet business requirements and deliver quality products.
Regulatory Affairs Services
Regulatory Affairs

We interpret fundamental regulatory requirements and advise you on how they affect the submission and marketing of your products.
Validation and Qualification Services
Validation & Qualification

We conduct and document thorough tests of your systems, processes, and equipment to ensure they’re both effective and efficient.
Business Strategy Services
Business Strategies

We help you integrate lasting capabilities and work hands-on with your organization to mobilize effective change and adaptability.
GMP Documentation Services
GMP Documentation

We create, develop, and implement documents that are clear, concise, and communicate exactly how you operate your systems.
Technical Services
Technical Services

We offer subject matter expertise to effectively manage your product development, technology transfer, and sustainable commercial manufacturing.
Project Management Services
Project Management

We take the extra steps necessary to ensure thorough execution of your project needs, utilizing the latest tools, and drive project teams to deliver results on schedule.

WHY PROTOCOL LINK?

OPERATIONAL EXCELLENCE

We provide outstanding service through teamwork, accountability and innovation.

COMMITMENT FOCUSED

We offer a confident, honest, and approachable end result.

INNOVATIVE SOLUTIONS

We refuse to settle for quick fixes and cookie-cutter solutions.

SUBJECT MATTER EXPERTISE

We are composed of seasoned, industry-experienced consultants and leaders.

ATTENTION TO DETAIL

We are thorough, accurate, and custom-crafted to suit you.

PERSONAL APPROACH

We mobilize the right people and skill-sets in support of each of our projects.

Protocol Link provided a team of professionals with the experience and knowledge to quickly identify our operational and quality compliance needs. They provided realistic recommendations and practical remediation actions, resulting in the strengthening and enhancement of our overall Quality System.
Excelsior
Vice President RA/QA
I wanted to let you know how much I appreciate all the help you and your team have been to our company and me personally over the years we have worked together. It's been a privilege and a pleasure working with all of you.
Cardinal Health
Director, Quality & Regulatory Affairs
We have utilized Protocol Link's experienced talent pool in a variety of Quality and Compliance applications over the last 10+ years. The unique value of Protocol Link is the ability of the team to work hands-on in an effective, pragmatic fashion with our team. They've been a cost-effective solution to a number of our needs.
Actavis
SVP - Global Quality
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