News

The Latest

Marken Successfully Ships Lifesaving Treatments For Humanitarian Aid In Ukraine

GOAL As part of a humanitarian effort responding to the ongoing crisis in Ukraine, Marken was requested by a client to ship critical compassionate use medicinal products and supplies. CHALLENGES These requested clinical supplies were currently not available in th...

  • Marken Successfully Ships Lifesaving Treatments For Humanitarian Aid In Ukraine

    GOAL As part of a humanitarian effort responding to the ongoing crisis in Ukraine, Marken was requested by a client to ship critical compassionate use medicinal products and supplies. CHALLENGES These requested clinical supplies were currently not available in the region to aid Ukrainian refugees. These shipments required a 48-turnaround time (TAT) in order to… Read more »

  • Marken Service Update: State of Emergency Declared in Ecuador

    Marken is closely monitoring the impact of the State of Emergency declared in Ecuador. We understand your concerns and the challenges that may transpire throughout the supply chain. With close communication with our regional Marken team, we are currently receiving real-time updates and have prepared contingency plans in place, to mitigate disruption and ensure uninterrupted service.… Read more »

  • UK Consultation on Proposals for Legislative Changes for Clinical Trials

    Author: Anna Cesar – Manager, Regulatory Compliance EMEA The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has ran, from January 17 to March 14, a public consultation on 10 issued proposals regarding the regulation of clinical trials in the UK. These proposals aim to revise the current Medicines for Human Use (Clinical Trials)… Read more »

  • CDC Noninfectious Certification Statement

    Recently the Centers for Disease Control (CDC) reminded the trade community that shipments of noninfectious diagnostic specimens must be accompanied by a noninfectious certification statement. Providing CDC with a non-infectious certification statement is not a “new” requirement. Title 42 part 71 The Foreign Quarantine regulations state that noninfectious diagnostic specimens may be imported without an… Read more »

  • FDA Launches New 24/7 Drug Entry Review Pilot

    Author: Anna Cesar – Manager, Regulatory Compliance EMEA From March 13, 2022, through June 13, 2022, the Food and Drug Administration’s Office of Regulatory Affairs’ Office of Enforcement and Import Operations (OEIO) will run a new entry review pilot. The pilot has been developed as a way to improve their operational efficiency on account of… Read more »

  • Service Update – South Africa

    Over the past several days, we have been closely monitoring the developments regarding Omicron, the new COVID-19 variant identified in Africa. To comply with new regulations, the majority of our commercial carrier partners have announced that they will transition to cargo-only flights out of Johannesburg, South Africa. Additionally, some airlines are operating on restrictive service,… Read more »

  • Closely Monitoring Tropical Storm Ida

    Following the landfall of Hurricane Ida, we understand that many clinical sites in the South-Central part of the U.S. may be impacted. We are working proactively with clients to provide alternative arrangements to ensure patients are unaffected and making contingency plans to ensure uninterrupted service. Please contact your local Marken branch or business professional if… Read more »

  • Canada New Client Portal

    AUTHOR: Anna Cesar | Regulatory Compliance Associate The Canada Border Services Agency (CBSA) is modernizing and streamlining the process of importing commercial goods. The CBSA Assessment Revenue Management (CARM) solution will give importers and brokers 24/7 access to border services through the new CBSA Assessment Revenue Management Client Portal (CCP). Canada’s importers and customs brokers… Read more »

  • UPS HEALTHCARE PARTNERS WITH THREAD TO DELIVER

    New, comprehensive in-home visit solution provides seamless digital experiences for clients and patients for decentralized clinical trials Research Triangle Park, NC, and Cary, NC, June 29, 2021 – UPS Healthcare’s clinical trial logistics unit, Marken, and THREAD, an innovative decentralized clinical trial technology provider, announced a partnership today to bring the first ever, unified, decentralized… Read more »

  • The New European Medical Device (MDR) and In-Vitro Regulation (IVDR)

    AUTHOR: Anna Cesar | Associate, Regulatory Compliance The transition period for the new European Medical Device (MDR) and In-Vitro Regulation (IVDR) will end soon – May 26, 2021, and May 26, 2022, respectively. If you are an importer of medical devices or IVDs to the EU, you must be prepared for changes. Importer role under… Read more »

  • Show More