With an epidemic proportion of obesity growing, prominent financial researchers predict the obesity drug category will exceed $100 Billion by 2030. Ensuring success boils down to meeting trial timelines and SIV dates.
Any missed opportunity delays your trial, impacting the drug’s time to market and resulting in lost revenue.
Time to market can be do-or-die for a growing biotech.
Running clinical trials is complex without having to concern yourself about country-specific compliance regulations and taking on the risk of importing medical goods in your name.
Research indicates that the total number of GLP-1 obesity drug users will be around 9% of the US population by 2030. That’s a potential 19 million people who could benefit from this ground-breaking drug
Drugs like Wegovy can make massive contributions to the global healthcare system. Obesity drugs have a significant impact on secondary burdens such as cardiovascular disease and other non-communicable diseases (NCDs).
Many biotech companies are pushing boundaries within the clinical trial space for obesity drugs (link to news piece), and with the current demand exceeding supply – any delays in your obesity drug trial can be detrimental.
Our global customs expertise has allowed for a 46% reduction in the time required to get the necessary import licenses for various regions.
Relax knowing that your products will meet SIV dates and compliance requirements without any worries.
Let TecEx act as your obesity trial project manager, facilitating compliant and efficient global clinical trials. See how we enable biotech companies to run global clinical trials for obesity drugs.
Biotechs and Obesity Clinical Trials | How We Help
TecEx Medical specializes in IMP customs clearance worldwide.
Through our bespoke global logistics and customs compliance solution, we enable the deployment of clinical trial commodities to clinical trial sites across the globe.
TecEx Medical’s IOR Project Management solution includes:
- Importer of Record
- Customs compliance
- Customs brokerage and clearance
- Logistics
- Tax reclaim (if applicable)
With obesity trials taking place globally and recognizing that each country has unique customs compliance variations, regulatory approval processes, and country-specific nuances, TecEx Medical can assist you with importing clinical trial goods to any location.
Some of the more complex lanes we have encountered for obesity clinical trials include:
Importing Obesity Clinical Trial Commodities To:
The Americas
Argentina
Complex customs requirements make this country notorious for customs clearance and lead times. Our extensive knowledge and understanding of the ANMAT submission process ensure no added waiting time. Following this, TecEx Medical will apply for the required 12-puntos import license directly after ANMAT approval, ensuring no delays.
Brazil
Another notorious country due to the ANVISA approval process. Something TecEx Medical is well-versed in achieving.
Mexico
We advise you immediately on the required listing of importation products in the COFEPRIS submission process to avoid any lengthy amendments at a later stage. Following approval, we also apply for the required NOM-import license.
United States of America
While most companies have a legal presence in the US and import themselves. TecEx Medical supports our clients as the recorded IOR on the IND application to the FDA – which results in quick and efficient clearances into the US.
Asia-Pacific
Australia
Australian customs officials are particular about how products are listed on shipping invoices. Furthermore, additional compliance documentation is required if the IMP contains animal-derived information.
South Korea
TecEx Medical ensures the timely application of import permits to the MFDS, thereby decreasing lead times and meeting SIV dates.
Taiwan
We apply for the TFDA Import License on your behalf. This can become complex as the quantity of IMP listed on the permit is the only amount that can be imported. If additional IMP is required, a new import permit must be applied. Through our project management tool, TecEx Medical keeps track of the quantity imported and what is still available on the import license. We will apply for an additional permit promptly to ensure there are no delays caused by the initial quantities being exceeded.
Obesity Clinical Trial Commodities We Ship
Clinical trials are more than just the drug being tested. Many additional products must be shipped to the various sites for the trial. These products must be imported correctly and compliantly, leading to a lot of administrative work and compliance research to ensure customs clears the goods.
In general, this is what to expect when conducting an obesity clinical trial:
- The investigational product: This requires varying legislation and regulatory approval before the shipment can clear customs
- Tech products: From tablets to eDiaries, patients are often expected to record information on eCOA devices. Clearing technology through customs requires expertise due to the dual-use nature of the goods.
- Medical devices: These can range from tape measures to sphygmomanometers, all requiring identification through HS codes to facilitate importation.
- Biological samples: As well as any collection instruments. If any samples need to be exported, a specialist IOR will be required to facilitate the customs clearance as we handle any additional supply chain procedures (e.g., cold storage).
- Lab kits: Again, kits contain various instruments, each with corresponding compliance regulations. Our compliance database ensures we can accurately identify the product and that all permits and licenses are applied for.
- Patient Recruitment Material (PRM): Did you know you still require an IOR to import paper material (e.g., leaflets) to your clinical trial sites? We can help you.
As you can see, having a specialist clinical trial IOR can help you clear customs efficiently and effectively and get your goods to the site before SIV.
Get ahead of your competitors with TecEx Medical and enter the market.
