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Specialty Consulting

From a regulatory standpoint, managing a complex crisis like the current pandemic requires a strategic response to challenging and fast-changing circumstances.

These challenges are compounded by the lack of an established regulatory framework for this situation. The world has turned to the pharmaceutical/biologics industry for solutions, and the pressure has fallen on Health Authorities and drug development companies alike.

While COVID-19 has not been a common occurrence, industry is confronted with the reality that somewhere around the corner, another public health emergency is looming.

This is where true partnership happens.

In 2020, G&L demonstrated that it was able to rise above the uncertainty around what the COVID-19 treatment landscape would look like and was in the trenches along with the rest of the healthcare industry.

How we helped

Our regulatory experts provided timely intelligence (monitoring the global landscape), recommendations, and technical support that allowed sponsor companies to effectively mitigate the impact of the pandemic on their ongoing clinical trials.

We were tasked to scrutinize data and provide analyses on when to approach regulatory bodies for critical filings like Emergency Use Authorizations.

Our team responded by identifying key opinion leaders and supporting virtual advisory boards, while making presentations to executive leadership and their investment community/ies in parallel. This is just one example of the breadth and depth of competencies at G&L.

Our services include:

  • Emergency Use Authorization
  • Litigation support
  • WHO Prequalification and Registration
  • Risk Evaluation and Mitigation Strategy (REMS)
  • C-suite/investor relations presentations
  • KOL/Advisory Board meetings

Contact us today

For more information on Specialty Consulting, please fill in the form and we will respond to you as soon as possible.

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