The pharmaceutical industry is navigating a time of increasingly complex drug development and manufacturing processes, yet the pressure to accelerate the time to market is rising. Finding strategic solutions to improve efficiency and reduce risk – while maintaining strict quality and compliance standards – is more important than ever.
Bringing a new drug to market is a costly, lengthy, and risky process. A study of 38 new drugs approved by the United States’ Food and Drug Administration in 2019 found a mean investment of $369 million in direct costs for each successful drug, but a staggering $1.3 billion cost after capital and development program discontinuation adjustments, such as the cost of failed projects.
Pharmaceutical companies must compete in a challenging environment that includes rising development expenses, increasing treatment specificity, stringent quality and regulatory expectations, and the need for commercial viability. There is a constant demand for a smarter approach to drug development, manufacturing, and supply. Here, partnering with an end-to-end contract development and manufacturing organization (CDMO) can be a strategic asset – consolidating services under one provider allows pharmaceutical companies to streamline processes, enhance efficiency, and mitigate risks throughout the entire process from early development to commercialization.
Challenges for pharma companies
Pharmaceutical companies often outsource aspects of drug development because they have limited in-house capabilities or capacity in areas such as formulation development, clinical trials, quality control (QC) testing, manufacturing of specific dosage forms, packaging in certain presentations or insufficient infrastructure for the handling of high potent APIs. Outsourcing to CDMOs lets companies focus on their core competencies and tap into the specialized knowledge and advanced technologies necessary for success.
Many companies with early-stage assets may choose to outsource different stages of drug development to multiple vendors. This fragmented approach is evident across the drug development timeline, from preclinical work to both early- and late-stage clinical trials and, ultimately, commercialization (Fig. 1).
When outsourcing to multiple service providers clients become the coordination point between multiple CDMOs, which can create challenges for communication and oversight.
This approach involves risks, as highlighted by Lora Wallis, Head of Delivery – Pharma at Douglas CDMO:
“When working with multiple parties, often the only point of commonality is the client themselves, placing a significant project management burden on the client. Without considerable resourcing to manage the contracts and responsibilities of each vendor within the project there can be miscommunication, inefficiencies, and a lack of cohesive oversight between all parties. Important details can easily be overlooked. In contrast, with an end-to-end CDMO service, both parties have a vested interest in ensuring every aspect of the project is covered.”
A fragmented approach can also lead to gaps in the development timeline and hamper the sharing of important knowledge and information. These inefficiencies often slow development and add significant costs, with a recent study highlighting that even a day’s delay in drug development can cost $800,000.
The power of an end-to-end CDMO partnership
The hidden costs of working with multiple vendors can quickly add up. Lora explains that delays, inefficiencies, duplicated efforts, and increased project management each have a cost:
“Each handoff between vendors creates a risk of knowledge loss or misalignment, leading to costly setbacks. An end-to-end partner streamlines the process, minimizing rework and ensuring development stays on track. In the long run, this translates to a significant financial advantage by accelerating time to market and optimizing overall costs.”
Douglas CDMO appoints a project manager to each client’s project. These project managers sit centrally and have direct access to every team involved in the development process. At Douglas CDMO headquarters, all key functions—from research and development to manufacturing and commercialization—are housed in one physical location. As Lora explains,
“This proximity enables seamless communication, faster problem-solving, and real-time decision-making. Instead of delays caused by coordinating across multiple vendors who are scattered between locations, teams can simply walk from one department to another, reducing unnecessary administrative burden and keeping projects on track.”
Lora Wallis, Head of Delivery – Pharma
Balancing specialisation with long term vision
Pharmaceutical companies must navigate challenges of vendor coordination and also an increasingly complex global regulatory landscape. Each market has unique requirements, and maintaining compliance with evolving regulations across multiple regions can be daunting for sponsors in the early stages of development. Using a single CDMO that adheres to good manufacturing practices (GMP) streamlines this process, eliminating the risks associated with fragmented vendor management.
A unified approach with consistent GMP compliance from preclinical phases through to commercial manufacturing prevents costly regulatory delays that often arise when multiple – potentially non-GMP compliant – parties are involved.” Lora highlights how these issues can arise when multiple parties are involved across different stages of drug development:
“It can be tempting for sponsors to choose a non-GMP-compliant supplier for preclinical phases because they are often less expensive in the early phase when the sponsor may not be sure of a positive outcome. But once clinical trials begin, GMP becomes critical, and if the processes used by a non-GMP compliant supplier are not transferable to the next phase, this may require additional validations that end up costing more than what was saved in the first place, and take significantly longer.”
LORA WALLIS, HEAD OF DELIVERY, DOUGLAS CDMO
Tapping into the right skillset at the right time
End-to-end CDMOs are structured to encompass the entire drug development and manufacturing lifecycle and are able to adapt rapidly to respond to evolving challenges. The key to this is access to a diverse range of specialized skills, often spanning multiple scientific and operational disciplines.
Lora explains that clients appreciate the breadth and depth of experience in Douglas CDMO, which has developed over 40 products that have been launched in over 50 markets:
“We have an extensive knowledge base and seamless access to our in-house teams like clinical operations, intellectual property council, and global regulatory affairs teams, to name a few. Our team’s innate curiosity and problem-solving ethos spans from early-stage development through to late-stage processes, encompassing everyone from formulators to packaging line personnel.”
Supply chain resilience
End-to-end CDMOs can offer significant supply chain resilience, especially in times of global disruption. During the COVID-19 pandemic, countries imposed varying restrictions on manufacturing and logistics, so pharmaceutical companies with fragmented supply chains faced significant disruptions. Lora explains that companies managing multiple contract manufacturers had to navigate variable and often changing regulations, which resulted in stalled production and delayed timelines. In contrast, Douglas CDMO’s fully integrated model allowed operations to continue.
“We were supporting a novel drug application for the U.S. during that time, handling everything from clinical supply through to registration and commercial scale-up, all under one roof. When launch batches were scheduled, COVID-19 hit, creating a logistical nightmare for many. But because we controlled the entire process internally, we met every milestone without impediment to the client.”
Moreover, Douglas CDMO’s established track record and strong relationship with the FDA, built over years of consistent quality and compliance, contributed to an efficient approval process and a smooth U.S. product launch.
Douglas CDMO: the smart choice for pharma
Douglas CDMO has proven in-house expertise that translates into success as an end-to-end CDMO service provider. Over more than 65 years, Douglas has invested heavily in the training and continuous development of its team and infrastructure, ensuring it uses cutting-edge technology and has a highly skilled workforce.
“Our company is proud to have employees from over 50 different countries,” says Lora. “Diverse backgrounds bring professionals with a wealth of international experience to the team. This enhances our ability to tackle challenges in the drug development industry and provide comprehensive end-to-end services.”
Douglas CDMO’s success in innovation is driven by this talented workforce, whose expertise spans both generic and innovative drug development. This breadth of experience allows the company to manage complex projects seamlessly from conception to market, a key advantage of an end-to-end CDMO partnership. Lora highlights one such success, where a development required a Paragraph IV ANDA (Abbreviated New Drug Application) filing: “We successfully filed the Paragraph IV ANDA, enabling the company to launch the product before the existing patent expired and ahead of generic market saturation, securing a significant competitive advantage.”
Together, the perfect formula
The strategic advantage of partnering with an end-to-end CDMO lies in its ability to provide access to a comprehensive and integrated pool of expertise, fostering agility, efficiency, and consistency, so clients can navigate the complexities of drug development and manufacturing with greater confidence and success. Douglas CDMO’s expertise and track record make it the smart choice for pharmaceutical companies seeking a reliable, capable, and forward-thinking partner from initial conception to market launch.
References
Mulcahy A, Fennane S, Schwam D. Use of clinical trial characteristics to estimate costs of new drug development. JAMA Netw Open. 2025;8(1):e2453275. Doi:10.1001/jamanetworkopen.2024.53275.
Smith Z, DiMasi J, Getz K. Quantifying the Value of a Day of Delay in Drug Development. Tufts Center for the Study of Drug Development; 2023. Available at: https://9468915.fs1.hubspotusercontent-na1.net/hubfs/9468915/Day%20of%20Day%20White%20Paper%20Final.pdf. Accessed March 11 2025.
Other posts you may be interested in...
Articles
Focused CDMO solutions: The strategic advantages of mid-sized providers
Douglas CDMO is making its mark in the pharmaceutical development industry with their flexible and personalized approaches to client needs.
Learn MoreArticles
Bespoke client solutions: A personalized approach as a privately owned CDMO
Douglas CDMO is making its mark in the pharmaceutical development industry with their flexible and personalized approaches to client needs.
Learn MoreArticles
CRO, CMO, and CDMO partnerships: A guide for pharma and biotech companies
Susan Lynch-Smith, Head of Business Development, Douglas CDMO, discusses the critical role that CRO, CMO and CDMO partnerships play in R&D and drug development.
Learn MoreArticles
The case for softgels: Addressing stability, shelf-life, and bioavailability issues in pharmaceutical formulation
Softgel formulations can often address the stability, shelf-life and bioavailability challenges encountered in the development of oral medicines but require specialist expertise to deliver …
Learn More