Your trusted advisor for regulatory compliance strategies.

iClinical Health is committed to helping clients achieve their global regulatory goals, most cost-effectively, on time.

The Regulatory Compliance Experts.

With both globalization and the increased understanding of risk comes a growing demand for regulation. Changes in regulation mean companies require tools and solutions to facilitate regulatory review and compliance.

 

In some cases, meeting the regulators’ needs is straightforward. However, in some cases, gaining access to necessary data can take time, money, and effort, which raises costs but doesn’t necessarily increase revenue.

 

iClinical Health offers a solution. Our Regulatory team is responsible for ensuring that our client’s software conforms to all regulations. We work closely with the FDA & EMA about getting required information into the electronic medical record (EMR) and help write software that could satisfy regulations.

Regulatory Affairs Consulting Services for Pharmaceutical & Biotech Companies

Authorities heavily regulate the life sciences industry. And it wouldn’t be possible to develop medicine without having a team of regulatory professionals ensuring that products under development are meeting global regulatory standards.

 

At iClinical Health, we understand that navigating a complex global regulatory arena is no easy task. Our regulatory experts are available to ensure that you get the attention and support throughout the product development lifecycle, from pre-clinical trials to market approval for market release.

The world of medicine continues to evolve at an ever-increasing rate.

There are so many changes that happen daily. iClinical Health is here to help any time of the day. Please get in touch with us for more information on our Regulatory Compliance Services and how we can make them work for you.

We have helped many organizations with the whole gamut of regulations and compliance requirements, including

  • Regulatory Strategy
  • Regulatory Submission Planning
  • Advertising/Promotion Review and Compliance
  • Pharmacovigilance Processes
  • Marketing Applications
  • Launch and Post-Approval Activities
  • Clinical Trial Authorizations, Maintenance, and Trial Support