Navigating Country Certification Lead Times

Insights from an Global Market Access Industry Expert

In the ever- changing world of Global Market Access (GMA), meeting production and launch deadlines can feel like navigating a maze of lead times, certification requirements, and logistical challenges. As someone with over ten years of being deeply entrenched in project management and operations within this industry, I’ve dealt with the dreaded question: “If we start now, can we ship by X date?” It’s a question that underscores the intricate dance between customer expectations, regulatory compliance, and operational efficiency. 

Kat Venardi, Director of Operations

The Intricacies of Lead Time and Logistical Planning

One of the critical factors in determining whether a shipment can meet its deadline is understanding country certification lead times. These lead times are not static; they vary from country to country and are influenced by a wide variety of factors ranging from regulatory changes,public holidays and even unforeseen catastrophic events. Moreover, the clock on these lead times doesn’t start ticking until the certification application is officially submitted with all the required documents to the certification body and/or testing commences at local laboratories. One missed step in the preparation for these milestones can cascade into delays that jeopardize the entire production timeline. 

Before diving into best practices, there’s a laundry list of prerequisites:  

  • Collecting technical documentation 
  • Configuring samples 
  • Navigating customs clearance—the list goes on.  

Each of these steps demands meticulous planning and execution to ensure smooth progress toward certification. 

How to Streamline Project Planning with Technology

So, how do we wrangle these complexities into a coherent project plan that aligns with our customer’s production goals? It’s simple – technology. At Global Validity, we’ve developed a proprietary global market access platform that leverages automation and data analytics to streamline the project planning process. 

Our platform intelligently calculates major milestone dates based on customer deadlines and current country lead times. Resulting in a detailed, organized schedule, country by country, pinpointing key milestones essential for on-time delivery. With clear indicators highlighting progress and most importantly potential risks, so stakeholders can stay informed and proactive in addressing any challenges that arise. 


Here’s a transparent glimpse of what such a project schedule might look like: 

In this hypothetical schedule, each country’s certification journey is mapped out, with milestone dates clearly delineated.  

  • Green indicators = milestones that are on track
  • Yellow or red = flag potential risks that require attention. 

Planning a Successful Country Certification Journey

For example, a manufacturer anticipates shipping the product to Chile by July 15, 2024 (the launch date). That means, all documentation must be received by April 8, 2024, to allow sufficient time for review and submission to the CB no later than April 22, 2024. These dates are determined based on the current average lead time in the country and, although not a guarantee, offer stakeholders the best chance to meet their internal deadline. 

access manager timeline

How We Empower Businesses for Success

Staying ahead requires not just expertise, but also innovative tools that streamline processes and mitigate risks. By leveraging technology to navigate the complexities of country certification processes, we empower businesses to confidently meet their production deadlines, ensuring timely market entry and competitive advantage. 

Join us at Global Validity as we redefine the possibilities of efficient global market access. 


Global Validity is your partner for global certification success

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