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Brexit Blog Series: Brexit, quo vadis?

October 11, 2019

Brexit, quo vadis? Almost 100 years after the Republic of Ireland left the United Kingdom, dividing the island in two...

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China to Implement a Major Update to Its Drug Administration Law

September 18, 2019

Authors: Peiling Shih, Executive Director, Regulatory Strategic Development, APAC Sarah Qu, Associate Director, Regulatory Strategic Development, China The National People’s...

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China Releases Draft eCTD Submission Information

August 29, 2019

In recent months, China’s Center for Drug Evaluation (CDE) has released draft information regarding the future of electronic common technical...

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Clinical Trial’s Most Valuable Asset

June 28, 2019

Do you know what the most valuable asset from your clinical trial is? On June 12, 2019, the Duke Margolis...

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60-Day Review for Clinical Trials Works in China

May 23, 2019

The days appear to be over when obtaining regulatory approval for clinical trials in China generally took a year and...

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Brexit Blog Series: The Fog Remains

March 25, 2019

Recently, the British Parliament voted three times on Brexit. Based on the outcomes, the most likely scenario will be a...

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Recent Biotech IPO Analysis

March 25, 2019

Investor interest in biotechnology companies has been extremely high over the past several years. Previous articles have discussed the increase in biotech FDA...

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Biotech FDA Approvals Peak

February 21, 2019

Last September, I discussed how increased biotech funding is having a material effect on overall pharmaceutical research and development spend. The output of...

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Biotech’s Impact on Drug Development

September 5, 2018

Private and public funding for biotechnology investments have occurred at a record breaking pace over the past twelve months. Incredibly, according to...

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EMA Issues Guideline on GMP for Advanced Therapy Medicinal Products

January 2, 2018

  On November 22, 2017 the European Commission published the first guideline for GMP for Advanced Therapy Medicinal Products which...

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