Certus International

Expert Consulting

Our Professional Consulting Services

Our professional consulting team has decades of experience finding solutions and is ready to provide the answers you need. Working in partnership with our sponsors, whether the situations are CMC, QA, clinical trial, advisory board, or research & development related, we are prepared to deliver valid, long-term solutions to any challenges you may face.

Solution Services

Certus International delivers solution services. We listen to our clientele's needs, then use our experience to deliver solutions that produce targeted results!

Expert Panels

By identifying key areas, Certus International team members can organize and participate in product-specific panels and advisory boards!

Research Planning

Through close collaboration and an honest approach, our professional consulting team knows how to plan your product's research and development pathway!

Solution Services

We at Certus International take pride in the rock-solid team we have built over several decades of providing solution services to our clients.
Most of our consulting team members are seasoned experts who have functioned as Vice Presidents, Medical Directors, and Department Heads for some of the largest companies in the research industry.
Our consulting team tackles challenges in the arenas of Quality Assurance, Regulatory Affairs and FDA Submissions, Scientific Affairs, Clinical Trial Design, Statistical Analysis, and Imaging Core Lab Management.
Our strong history of success gives Certus International’s consulting team the experience to deliver project-based solutions and to seamlessly transition toward managing clinical programs.

An Executive CRO

Certus has been described as an “executive” contract research organization, meaning many clients use Certus staff as senior team members for their organization, developing regulatory strategies.

We'll Take on Responsibilities

We work closely, as trusted partners, streamlining procedures and maximizing teams’ available resources. We can help fill management and executive responsibilities on a temporary or long-term basis.

Real World Experience

The Certus International team has working experience and proven competency in fields throughout the industry that include imaging, diagnostic, therapeutic drugs, biotechnology, clinical trials, regulatory affairs, and device products.

Solution Services Offered

Multiple Experts

We understand how to identify key areas that need to be addressed during product development. When issues become too complex for just one, we have multiple experts who can step in at any time to assist.


Certus team members organize and participate in product-specific panels and advisory boards, providing additional insight into clinical trial and product planning issues, particularly those in PET, radiopharmaceutical, and other imaging areas.

Targeted Improvement

Panels and advisory boards have the ability to identify target areas requiring increased or better clinical endpoints, additional research, and marketing strategies.

Advisory Board Services

Expert Panels

When we organize expert panels, we use our extensive academic and professional relationship networks, built from years of experience in the industry. 

Our networks include a number of accomplished academic personnel, former FDA employees, and industry veterans who have the real, hands-on experience and progressive vision necessary to solve the issues.

Research Planning

Determining the most efficient pathway to market is a difficult task. 

With the number of potential regulatory pathways available to drug developers, having an expert who understands the system and can guide you through the submissions and appropriate product designation choices is priceless

We Can Guide You

Through close collaboration with your team and a careful but honest approach, Certus International knows how to plan a product’s research and development path.

Submitting to FDA

We know which nonclinical studies are necessary for your product development. After collecting all data, we're able to incorporate the information into an IND submission, then write, format, and submit the information to the FDA in CTD format.

Resource Planning

Resource Planning is extremely important. Investors and grant applications often require a development plan outline, with timelines, cost estimates, and contingency plans. We can put this together for you.

External Verification

Investors hold the external verification of resource planning in high regard. Certus International has happily performed this function several times, helping clients who have insufficient staff and/or experience to put together such a plan themselves.

Want to know more? Let's Talk!

Are you looking to start a clinical trial?  Do you need trial management or regulatory help?  We have you covered!