3 Critical Questions to Ensure Your API Partner Can Protect Your Supply Chain

The right API partner doesn't just deliver chemistry; they strengthen every link in your development and supply chain. As programs move from discovery to commercialization, the complexity grows, and so does the need for reliability, transparency, and speed.

To help you identify partners who can provide true long-term value, we spoke with Dr. Grace Jung, Principal of Jung Pharma Consulting, who has guided global pharma organizations through every stage of API development and scale-up.

Dr. Jung shared three essential questions that reveal whether a partner can not only meet your technical needs but also protect your program from unnecessary delays and disruptions.

Can They Respond Quickly When Problems Arise?

Dr. Jung emphasizes that a prospective partner’s communication infrastructure may be just as critical as its production capability.

“You need to understand their process for handling mid-production issues and client notification before problems arise, not during a crisis,” she said.

Time zone alignment directly impacts responsiveness. With North American partners, technical teams can collaborate in real time when issues emerge, minimizing the risk of small setbacks escalating into production failures. In contrast, working across a 12- to 15-hour time difference can mean a full day’s delay before a problem is even acknowledged.

Language barriers can further complicate communication. Batch records are typically executed in the local language, and translation requirements can slow response times just when rapid decision-making is most critical.

“Translation delays can slow responsiveness and decision-making precisely when you need to act quickly,” Dr. Jung noted.

By partnering closer to home, companies benefit from shared working hours, a common language, and aligned regulatory expectations. Dr. Jung stresses that these advantages enable more than just faster communication; they foster true partnership. The most effective relationships, she said, provide direct access to technical leads and regular joint planning sessions, treating the CDMO as a fully integrated partner rather than a transactional vendor.

Do They Have Reliable Logistics Infrastructure?

Even the best-manufactured API is useless if it degrades under inadequate controls during shipment. Timelines are impacted negatively if the API can't reach your formulation facility reliably and on time. The pandemic exposed how fragile long-distance pharmaceutical logistics can be, revealing bottlenecks in:

• Cold chain transport and temperature control
• Carrier capacity and route availability
• Cross-border coordination and regulatory clearance

Dr. Jung advises companies to verify a partner's logistics capabilities early, not just take assurances at face value.

“Don’t just accept assurances,” she cautioned. “Ask for their temperature monitoring protocols and their track record of maintaining stability during shipping.”

Cold chain integrity is only one part of the equation. Redundancy is another. Relying on a single carrier or shipping route can leave projects vulnerable when disruptions occur, whether from border closures, flight shortages, or regulatory delays.

“Verify they have backup shipping carriers beyond their primary options,” Dr. Jung said, adding that proximity makes a significant difference. North American partnerships eliminate many of the customs and freight challenges that delay overseas shipments.

Understanding realistic timelines from the manufacturing site to the formulation facility allows for more accurate project planning and fewer surprises.

“Don’t rely on promises about shipping times. Verify their actual track record and backup plans for when primary logistics routes fail,” Dr. Jung said. She advises that this diligence should extend beyond timeliness to the integrity of the supply chain itself, including continuous monitoring, incident response planning, and strict physical access controls to prevent adulteration or counterfeiting.

Do They Manage Their Own Supply Chain Proactively?

A manufacturer's ability to secure your supply chain depends heavily on how well they manage their own. 

Dr. Jung recommends evaluating four critical capabilities:

• Supply chain visibility
  Partners with mature supply chain management can map their suppliers, identify potential bottlenecks, and maintain relationships with alternate sources. 
  
  “You need to understand their raw material suppliers and lead times for critical starting materials,” Dr. Jung explained. This transparency becomes critical at a commercial scale, when material shortages can halt production and delay product launches. Supplier vetting is equally important: your partner should regularly evaluate the reliability and compliance of their vendors to minimize the risk of weak links in the chain.
• Collaborative forecasting
  Dr. Jung noted a shift from "just-in-time" inventory models toward strategic planning.“
  
  "Companies want partners who stockpile critical materials strategically, not just order materials as needed,” she said. Effective partners engage in collaborative forecasting, planning several months ahead and maintaining emergency reserves of key materials
• Proactive quality monitoring
  Detecting issues early prevents the loss of entire batches—an expensive setback both financially and in terms of time.
  
  “The worst thing is that you have impurities or aspects of your drug not meeting specs, and then you lose a lot of time trying to fix that problem afterwards. Then you've lost your batch,” Dr. Jung explained. She suggests that companies look for partners with robust monitoring systems that identify and address in-process problems before they compromise quality and that continuously scan for vulnerabilities across the broader supply chain to prevent unexpected disruptions.
• Intellectual property protection
  “IP protection and data security should be part of your evaluation criteria, particularly for novel compounds approaching commercial launch,” Dr. Jung advised. 
  
  North American manufacturers typically offer stronger safeguards through well-established legal frameworks and robust cybersecurity systems. According to Dr. Jung, this vigilance must also extend to the physical supply chain to prevent counterfeit or adulterated APIs during shipment and storage, a risk minimized by the tighter security controls common in the region.
  

Asking these three questions helps you identify partners who deliver not just quality APIs, but the long-term confidence, continuity, and security that define GL CHEMTEC's collaborative approach.

GLC: Your Strategic API Development Partner

GL CHEMTEC is passionate about your success and committed to solving your most complex chemistry challenges. We offer fast, flexible, cutting-edge solutions to take your API development and early-stage small molecule routes to the next level. Our commitment to a collaborative partnership means we scale and adapt precisely to meet your evolving needs.

GL CHEMTEC provides:

• A secure North American alternative to overseas providers, offering R&D labs, Kilo labs and scale-up facilities in the Greater Toronto area
• A local partner who will ensure secure shipping, real-time communication and the highest levels of IP protection for your early-stage work
• A highly customer-centric culture with a 20+ year track record of success
• ISO 9001:2015 and ISO 13485:2016 certifications
• A GMP Cleanroom with GMP Reactor Suites, offering GMP materials for clinical studies