Regulatory Affairs Support

With clinical trials taking place in more than 200 countries worldwide, navigating the diverse and ever-changing global regulatory landscape simply isn’t feasible without the guidance of an expert logistics partner.

 

Global Compliance Experts

Yourway has more than 20 years of experience distributing highly sensitive biopharmaceutical goods and clinical trial materials across all continents, affording us an innate understanding of global regulations and the agility to adapt to changing requirements at both regional and local levels. Prior to origination, your dedicated project manager will coordinate with our operations teams to develop a logistics strategy that takes into consideration your product profile as well as region-specific import requirements to mitigate the risk of noncompliance and prevent costly delays.

Through our depth of experience, regulatory agency relationships and ongoing industry research, we are continuously monitoring changes that could impact the movement of our customers’ materials, employing a proactive approach to ensure each shipment is delivered to the intended destination safely and efficiently – without interruption.

 

Regulatory Affairs Capabilities

  • Regulatory affairs consulting
  • Customs clearance support
  • Dangerous goods classification, preparation and documentation support
  • Packaging and labeling compliant with regional regulations.

 

Customs Clearance

As demand for niche therapies to treat orphan diseases drives clinical trials into remote, pharmerging markets, clinical logistics partners and import brokers are helping trial sponsors overcome regional compliance obstacles and clear customs without delay. Yourway offers comprehensive customs clearance support to help ensure the safe transport and on-time delivery of your biopharmaceutical shipments in all areas of the world.

Documentation Support

  • Document preparation and review to prevent shipments from being delayed, quarantined or destroyed
  • In-depth knowledge of regional and country-specific requirements in all areas of the world
  • Dedicated project manager supports the full scope of your global biopharmaceutical supply chain

Customs Duty Deferment Payment

  • Yourway pays duty fees on behalf of the customer for later reimbursement
  • Avoids waiting for authorization of payment at the port, helping to prevent costly, potentially detrimental delays

Commercial Invoice Assistance

  • Commercial invoice preparation for the import and export of all shipments containing non-documents
  • Ensures proper importation control, valuation and duty determination