Regulatory Risk Mitigation for Global Pharmaceutical Supply Chain Management
Marken announced recently the launch of the ‘Marken Consultation Services’. The new service provides global customs and agency regulation expertise for the pharmaceutical industry.
Import and export requirements are increasingly more complicated with ever-changing industry guidance and governmental regulations. Marken has been able to overcome these regulatory challenges for their customers, which has contributed to its reputation for quality service. Marken keeps up to date with these changing regulations and provides solutions when necessary in order to keep shipments on time and on spec. Marken experts include licensed customs brokers, import specialists, and life science experts, totaling more than 100 years of combined trade and regulatory compliance experience.
“Navigating US customs and government agencies for shipping drugs, biologics, specimens and API’s is a daunting and time-consuming task for the pharmaceutical industry, but this is what we do. We are offering this service to clients seeking advice before they start their planning. We engage clients early in their process so we can lead them through the maze of regulations, thus allowing them to focus their energies on research and development” said Dan Bell, Director, Commercial Operations, & Regulatory Compliance for Marken.
Regulatory Solutions offered as part of the new service
- Correctly classifying API to reduce customs & agency headaches and avoiding overpaying duties
- Ensuring compliance with trade laws and regulations for import & export
- Improving customs handling times for clinical trials materials
- Development of import strategies to significantly reduced import turn-around times
- Provide training on the regulations for every region to expedite global shipments
- Assistance with correct valuation for clinical trial material, including API, finished drug, ancillary/support equipment, and sample collection kits
Marken is the leading global clinical supply chain solutions provider dedicated to the pharmaceutical industry, supporting over 49,000 investigators in more than 150 countries. Marken integrates Depot and Logistics services that extend the reach of clinical trials to the most remote geographies, leveraging decades of experience in logistics, transport and distribution of temperature sensitive life saving pharmaceuticals, clinical trial supplies and specimen collection. For more information, visit www.marken.com