As a follow-up to our recent two-part series on Regulatory Starting Materials Sourcing & Supplier Management, we sat down with Senior Vice President of Supply Chain Management at Neuland Labs Dr. Sundar Narsimhan to get his take on finding and qualifying suppliers for regulatory starting materials (RSMs).

What was Dr. Sundar’s key takeaway? Invest the time necessary in supply chain management of RSMs upfront to minimize the likelihood of problems downstream – and across the drug lifecycle.

What tips and tricks can you share for identifying and qualifying a supplier of regulatory starting materials?

In my 15 years in the pharma industry, a sustained search of the supply base usually leads to the jackpot. Fine-tooth combing through high-quality databases like DWCP and Row2Technologies can unearth excellent sourcing options for any given API and its intermediates.

That being said, results can be hit or miss if NECs are involved, and commercial RSM options are limited. In that case, it may be up to the R&D team to develop a cost-effective manufacturing process for the starting material to facilitate commercial external manufacturing.

In your opinion, how crucial is supply chain management when applied to regulatory starting materials?

The criticality of supply chain management in the procurement of RSMs can’t be overstated. Lives are literally at stake, so the first objective of supply chain management is to ensure consistent application of cGMP practices.

As a professional in the pharmaceutical industry, the industry’s objectives of preventing deaths and illnesses while improving health have always been a point of pride, and I believe effective supply chain management is a huge part of that.

What’s the most important step in sourcing and supplier management?

Due diligence has always been an essential part of RSM procurement. If you’re looking to establish a long-term relationship with a supplier, you can’t afford to skimp on due diligence. Do due diligence on your due diligence, and you should be good to go with RSMs.

How do contract manufacturers like Neuland align their sourcing strategy with clients’ requirements?

Flexibility and proactiveness are the biggest secret ingredients. For instance, at Neuland, our global sourcing strategy means we have a wider reach when it comes to ensuring the desired regulatory status and cost competitiveness for each client. Our regulatory affairs and other teams have a wealth of experience with RSM sourcing, which provides greater confidence to clients seeking to mitigate business risks.

Any parting words of wisdom to pharmaceutical companies regarding supply chain management of RSMs?

Don’t overlook this critical upstream process because it can potentially impact downstream processes. That’s a key reason why you should always work with an API contract manufacturer that is familiar with RSMs, has well-established sourcing procedures and understands the chemistry. The benefits include better traceability from starting material to final drug substance, reduced time to commercial launch, lower development costs, improved supply chain security, and more.

Learn more about regulatory starting materials. For questions on regulatory starting materials and supply chain management, contact the Neuland team.