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Synteract Posts Regulatory Updates to Help Biopharma Clients Stay Current on International Regulations

CRO covers 42 countries in a Regulatory Surveillance Report to be issued three or four times per year

SAN DIEGO – July 15, 2013 – Synteract, a full-service global contract research organization (CRO), has completed a Regulatory Surveillance Report that provides regulatory updates on changes in legislation affecting clinical research worldwide. The company will post updates three or four times per year to help its biopharma clients stay up to date on international regulations. Synteract examines countries where the CRO has offices, affiliates and clients.

Synteract has collected information from 42 countries in regions including Central Eastern Europe, the Mediterranean, Scandinavia, the British Isles, Northern Europe, Israel, North America and Argentina. Regulatory and medical affairs experts from the company check local regulatory web pages for new guidelines, laws and regulatory requirements on a regular basis. Sometimes these are provided by industry organizations and associations. The report gives an overview of the collected information and explains the issued updates, but readers can find more details on government websites corresponding to each country. In addition, it includes the effective date of the changes and the area that was affected (product, population, investigator, administrative or other).

The purpose of the report is to help clients stay current on the latest regulatory requirements in countries where Synteract leads clinical trials. The CRO collects feedback from its partners and affiliates and writes a report to be posted on Synteract’s website. The information is accumulated and centralized in Synteract’s regulatory database to ensure thorough preparation for upcoming EC and CA submissions and provision of reliable information to sponsors. The Regulatory Surveillance Report is available free online.

Synteract has been formed from the merger of Synteract and Harrison Clinical Research (HCR), announced earlier this year. The newly expanded company operates from 16 countries worldwide and provides top tier international capabilities to support clinical trials globally, from emerging products through post-marketing.

About Synteract
Synteract is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With its “Shared Work – Shared Vision” philosophy Synteract provides customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 16 countries, Synteract delivers trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications. For more information, please visit or follow us at @Synteract.


Antonia Genov
+1 760-230-2424


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