India Regulatory Update
India’s CDSCO Calls for GDP Compliance to Safeguard Pharmaceutical Supply
The Central Drugs Standard Control Organization (CDSCO), the national regulatory body governing
pharmaceuticals and medical devices in India, issued draft guidelines earlier this year designed to ensure
the quality and identity of pharmaceutical products throughout the distribution process.
New European Offices, Thermal Packaging Alternatives Accommodate Specialized Needs of World Courier Biopharm Customers
World Courier has expanded its international network to 152 office locations in 52 countries with the recent opening of two new offices in Europe − one in Basel (Switzerland) and the other in Innsbruck (Austria) − once again bringing personnel and infrastructure closer to key clients in those countries.
“We have had a long history of continuously growing our operational network in response to customer demand,” says John Butler, Senior Vice President & Managing Director, World Courier Group. “We believe that this clear commitment to our clients permits us to deliver highly-customized and more responsive service while building stronger relationships between their local teams and ours. Ultimately, the better we know our customers, the better we are able to anticipate their needs and deliver viable and cost-effective solutions tailored to their unique circumstances. It’s all about enhancing communications and creating more options.”
Why a Closed-Loop Supply Chain System?
In the area of clinical trials, WORLD COURIER delivers unprecedented expertise in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens for one-stop global clinical supply support. WORLD COURIER’s fully-integrated GxP-compliant pharmaceutical supply chain system features a company-owned network of over 150 transport offices in more than 50 countries with GMP-compliant investigational drug storage depots in 13 strategic and emerging markets, strong knowledge of the local regulatory environment, and well-trained staff who operate according to global SOPs.
Ensuring Clinical Trial Success in the Russian Federation
In the area of clinical trials, WORLD COURIER delivers unprecedented expertise in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens throughout Russia and worldwide. It offers a fully-integrated GxP-compliant global pharmaceutical supply chain system, strong knowledge of the local regulatory environment, and welltrained staff and logistics networks worldwide. WORLD COURIER has operated company-owned offices in Russia since 1999 and utilizes its GMP-compliant investigational drug storage depot in Moscow as a hub to distribute clinical materials throughout the Russian Federation, delivering exceptional control and uncompromising accountability in a complex and often unpredictable environment.
Clinical Trial Logistics in India
In the area of clinical trials, WORLD COURIER delivers unprecedented expertise in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens throughout India and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply chain system, strong knowledge of the local regulatory environment, and well-trained staff and agent networks across India. With eight wholly-owned offices in India, WORLD COURIER utilizes its GMP-compliant investigational drug storage depot in Bengaluru as a hub for distributing clinical materials throughout the country. WORLD COURIER has operated wholly-owned offices in India since 1998.
Safeguarding the Global Pharmaceutical Supply Chain (Part 1)
WORLD COURIER’s Clinical Trial Supply Chain Services (CTSCS) division operates GMP-compliant investigational drug storage facilities in 13 strategic locations in Asia Pacific, Latin America, Africa and Eastern Europe. In conjunction with its proven GxP-compliant transport network of over 140 offices in 51 countries, no other international express courier offers a closed-loop clinical supply chain system of this scope, expertise, or capability.
Chinese Regulatory Changes for Human Serum and Plasma Exports Trigger Potential Delays
Researchers conducting or planning to conduct clinical trials in China should be aware of new regulatory changes that specifically affect export shipments of human serum and plasma from China and the delays that the new administrative process may create.
Choosing the Right Packaging “Fit” for Temperature-Controlled Shipments
With a fully integrated GxP-compliant transport, storage and distribution system in place and over 140 wholly-owned ISO 9001-certified offices in 50 countries, WORLD COURIER is the world’s largest and most experienced specialty courier company. It is uniquely positioned to meet the most demanding industry requirements for managing time- and temperature-sensitive clinical trial materials used in global studies.
The Urgent Need for Qualified Transportation Providers in Global Clinical Research
According to a recent study conducted by the U.K.-based Medicines and Healthcare Products Regulatory Agency (MHRA), a staggering 43% of critical and major product deficiencies are related to ineffective temperature control and monitoring during storage and transportation. Similarly the World Health Organization (WHO) recently maintained that 25% of all vaccine products arrive at their final destination in a degraded state.