5 Reasons Why More Pharma Companies Are Strengthening CDMO Relationships

The Biosecure Act may have been delayed, but even in its absence, compliance with existing regulations remains onerous. Furthermore, the new CSRD mandate comes into effect this year, adding more to the regulatory workload.

Meanwhile, competitors are advancing with AI/ML-driven drug discovery and pioneering gene and cell therapies. Supply chains are becoming increasingly unstable. Additionally, the consumer market, once predictable, now exhibits erratic fluctuations.

In the midst of this turmoil, scientists, CMC heads, and supply chain officers share a common goal: delivering high-quality drugs that meet regulatory standards and reach the market swiftly, with minimal resource expenditure.

One strategy for pharmaceutical companies to achieve this is by enhancing their partnerships with CDMOs. In this article, we will explore five current challenges faced by pharma companies and discuss how CDMO solutions can address them.

5 challenges faced by pharma companies

1. Compliance & Regulatory Risk Mitigation

The pharmaceutical industry has always faced compliance challenges. Between 1991 and 2021, the sector incurred $62.3 billion in financial penalties across 482 settlements due to compliance failures. Regulatory scrutiny is intensifying across the development and manufacturing pipeline. The FDA, EMA, and other global regulators are increasing expectations for transparency, data integrity, and adherence to current Good Manufacturing Practice (cGMP) guidelines.

This results in a challenging situation: maintaining compliance across global markets requires greater investment in data management, quality control, and audit readiness, diverting resources from core R&D and commercialization efforts.

Enhancing CDMO partnerships can help pharmaceutical companies navigate increased scrutiny:

• Regulatory expertise: Many companies already utilize CDMO pharmaceutical manufacturing services and benefit from their support in navigating evolving FDA, EMA, MHRA, and ICH guidelines. Neuland’s CDMO services can aid in managing regulatory requirements and advancing products through the development lifecycle. We have supported 3 NDA filings and 18 IND filings by supplying APIs and CMC documentation.
• Built-in compliance: Established CDMOs, such as Neuland, integrate regulatory CMC (chemistry, manufacturing, and controls) support, reducing compliance risks. Our processes strictly adhere to guidelines from the USFDA, EMA, and other health authorities. This encompasses manufacturing practices, quality systems, analytical methods, stability testing, and validation. Pharmaceutical companies partnering with us can expect meticulous documentation, adherence to GMP, and effective QMS. Learn more about our compliance support here.

For pharmaceutical companies operating in multiple jurisdictions, a CDMO’s experience with complex regulatory submissions and audit preparedness can be crucial in avoiding costly delays. Neuland’s customer base spans 80+ countries, providing extensive experience in various markets.

2. Drug Shortages & Supply Chain Disruptions

Hurricane-induced facility shutdowns, API shortages from China and India, geopolitical tensions…there have been countless supply chain disruptions leading to drug shortages. In 2023, we saw a record number of shortages; 323 cases. This has since been reduced to 277 drug shortages in 2024. However, even a single shortage is one too many.

Moreover, growing shortages have a ripple effect on all pharma companies. Regulatory agencies have taken notice. The FDA’s Drug Shortages Task Force has ramped up reporting requirements around manufacturing and inventory.

CDMO solutions can help pharmaceutical companies preempt raw material, manufacturing, and supply disruptions with dual-sourcing models and risk mitigation frameworks. Leading CDMOs like Neuland operate multi-region production sites, reducing your pharma company’s dependency on single-source suppliers. Over 25+ years of providing manufacturing services to large pharma and innovative organizations, we’ve perfected the art and science of supplier management.

3. Trending Demand Spikes & Market Volatility

Consumer-driven demand fluctuations are reshaping the traditional demand-supply paradigm. Influencer-led demand for products like collagen, multi-vitamins, and supplements is growing. Traditional manufacturing models may not accommodate rapid changes in demand efficiently.

Augmenting CDMO contracts allows pharmaceutical companies to respond to demand changes without investing in in-house capacity development. CDMOs enable scaling contracted production up or down based on market conditions. Neuland’s six-month sales cycle means a company can start working with us and receive its first purchase order within six months.

4. AI & Data-Driven Drug Development

Before leveraging AI as an opportunity, many organizations face challenges such as data silos, regulatory uncertainty around AI-generated insights, and integration bottlenecks. Internal teams often lack the resources to collect, clean, and analyze data.

CDMO solutions can support AI/ML efforts with established processes. Advanced CDMOs are integrating AI and ML into formulation and manufacturing workflows, reducing inefficiencies. At Neuland, we use AI/ML to optimize particle size distribution, enhancing formulation parameters and release behavior prediction.

5. Sustainability & CSRD Compliance (first CSRD reports due this year!)

With the EU’s Corporate Sustainability Reporting Directive (CSRD) mandating new disclosures on pharmaceutical emissions and supply chain sustainability, demonstrating progress in reducing Scope 1 & 2 emissions is imperative

Partnering with a CDMO with sustainable processes is an efficient way to achieve this. Neuland has been a member of the United Nations Global Compact since 2022 and actively pursues 8 of its SDGs.

Overcome 2025’s Top Challenges with Neuland

The months ahead may present challenges or opportunities for success. At Neuland, we can help you transform challenges into wins with our state-of-the-art R&D centers, capabilities, and expertise in synthetic chemistry, flow chemistry, and peptide APIs. Whether you need to increase production capacity, require compliance assistance, AI integration support, or sustainable manufacturing practices, we are here to help. That’s why we have been the CDMO of choice for numerous pharmaceutical companies for over 25 years. Augment, de-risk, and diversify in-house capabilities without compromising on quality. 

Contact us and explore your options today.

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