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Pre-approval communications prior to export: Why are they so important?

by Dan Polkowski

The best way to answer this question is with the catchphrase a chain is only as strong as its weakest link.  After 25 years of managing global clinical trial studies for clients, I cannot emphasize enough how much this phrase relates to the global distribution of ancillary/medical device supplies. Communication is one of those important links, from the beginning of your planning process to the very end — resulting in the successful door to door export of your goods.

To demonstrate this further, imagine a metal chain. All the links look new and strong on the outside, but in reality, there is a weak link. One link is weak from the inside, due to a crack that is not visible to the naked eye. Sometimes we look at our entire global distribution process without realizing that one of the processes might be our weakest link. No matter how much excellence you instill in your global distribution across all phases, your process will only be as good as your weakest link.

Global distribution is becoming a more critical and complex part of the planning process.  Early communication with all parties involved is paramount to success. Be vigilant and make sure your pre-approval communications include an evaluation of where the weakest link may be in your global distribution process.

Consider these topics when planning your global distribution. Any could be your weakest link:

  • Insufficient due diligence of the end user’s planned use of the product.
  • Importer of record (IOR), pharmaceutical/contract research organization or final delivery location (FDL) of medical/clinical site.
  • Your obligation of due diligence and to identify potential red flags for import of your ancillary/medical device supplies. Caveat: Not all countries are the same.
  • Knowledge (or lack thereof) of import regulations with all parties involved in country.
  • Verification of import license needs with your registered IOR and their assigned broker in country.
  • Verification of importer’s assigned broker and their effectiveness to assist with the customs clearance process.

An added communication security layer provides an additional opportunity to detect and stop threats early in your process, before your goods are exported. Pre-approval of communications support the potential to increase your on-time delivery needs with a high level of success. Building upon the success of your present pre-approval communications process allows you to increase your global penetration.

I hope this information has been helpful – if you need additional guidance, or have questions about the global distribution process of clinical trial supplies, just let me know.

To learn more about Imperial’s ancillary supplies capabilities, visit our website.

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