7 Key Points to Choosing the Right CDMO for Your Drug Product Development

With stringent regulatory and competitive pressures in pharmaceutical manufacturing, selecting the right partner for drug product development can determine whether a product advances smoothly to market or becomes delayed by costly setbacks and compliance issues.

A strategic contract development and manufacturing organization (CDMO) is the popular choice for drug developers to accelerate timelines, minimize risk, and add significant value across the product lifecycle. However, not all CDMOs are created equal.

In this article, we explore the key criteria to consider when selecting a drug product development partner and why you should consider Aenova for your next drug development project.

Learn more about our drug product development services.

By Dr. Klaus Pollinger, Director Global Product Development

As more CDMOs enter the market, it is increasingly difficult to distinguish between partners with proven capabilities and those whose offerings may be less robust than they appear. A truly strategic partner will offer more than just technical competence - and provide clear evidence of proven experience, robust quality systems, an understanding of clients’ evolving needs, and the operational flexibility to meet those needs.

1. Scientific and Technical Expertise

A CDMO committed to excellence should be able to deliver expertise across all stages of development, such as formulation, process development, scale-up, analytical support and regulatory strategy. By assessing their track record across different dosage forms (e.g. solids, softgels, injectables) and therapeutic areas, you will be able to establish whether they align with your project requirements.

It’s not enough to simply request a list of capabilities - you should seek evidence that backs this up. Ask thoughtful questions about how the CDMO has overcome similar challenges in the past, whether they have experience with molecules or programs comparable to yours, and how they leverage their expertise to deliver consistent, reliable results. Additionally, consider how efficiently and effectively they use your API, especially if it is costly or available only in limited quantities. For many small companies, maximizing API efficiency is crucial, so be sure to ask how the CDMO will help you move to the next phase while making the most of your valuable materials.

At Aenova, our multidisciplinary teams bring decades of experience successfully completing projects across drug product classes and manufacturing platforms. We work with both innovator and generic companies to support development projects ranging from orphan drugs to complex formulations requiring modified-release profiles, and from oral bioavailability enhancement to aseptic processing.

2. Integrated End-to-End Services

Managing multiple vendors adds complexity and risk. But choosing an integrated CDMO offers major advantages in terms of speed, communication, and quality continuity. A partner that combines all the essential functions under one umbrella minimizes project handovers, reduces timelines, and ensures that knowledge is retained throughout the lifecycle of the program.

A seamless handoff between development phases is particularly critical when facing tight deadlines or managing global supply chains, and it also enables more responsive decision-making by aligning all stakeholders within a single organization.

Aenova offers true end-to-end services under one umbrella. From early-stage development and clinical trial supply management to commercial production, our services are fully integrated and supported by global regulatory compliance. This streamlines project handovers and preserves institutional knowledge throughout the development journey.

3. Regulatory Experience and Global Compliance

Drug product development is as much about documentation and compliance as it is about scientific innovation.

A CDMO with global regulatory experience and a strong track record of successful filings with regulatory agencies (such as the FDA, EMA, and PMDA) will help you navigate the global regulatory landscape. It’s essential that your CDMO can demonstrate that they understand and meet regional requirements, submission formats, and the expectations of different health authorities.

Aenova’s regulatory teams are involved early in the development process to ensure that all activities align with current guidelines and future submission requirements. Our global network of GMP-certified facilities routinely undergoes inspections and support international regulatory submissions.

4. Flexible Capacity and Scalability

A strong development partner should be able to scale with you - not just in volume, but in complexity and geographic reach. Early-stage programs may require only small-scale GMP batches, but as a products advance through clinical phases and moves toward commercialization, the demands on manufacturing capacity, quality systems, and supply chain coordination grow substantially.

Identify a partner with a proven track record of supporting scale-up from clinical to commercial scale, with the infrastructure and regulatory approvals in place to ensure continuity and minimize the risks and delays associated with technology transfer or switching vendors mid-development.

With 14 manufacturing sites worldwide, Aenova offers flexibility at every stage of the product lifecycle. We can support small-scale pilot batches, clinical supply for Phases I–III, and full-scale commercial manufacturing – all with the same high quality and technical rigor.

5. Robust Project Management and Communication

Transparent communication and effective project management are critical for keeping development programs on track, particularly when working across multiple sites or regulatory jurisdictions. A capable CDMO should provide structured governance models, dedicated project managers, and clear communication channels to ensure alignment at every stage.

Proactive risk identification and contingency planning are especially important in complex drug development projects where unforeseen technical or regulatory challenges can emerge. Look for a partner that not only provides regular, data-driven updates but also demonstrates accountability and responsiveness in addressing issues as they arise.

Aenova assigns dedicated project managers to every client, serving as a single point of contact and ensuring cross-functional alignment. We use structured project plans, regular milestone reviews, and digital collaboration tools to ensure accountability and transparency.

6. Customization and Client-Centricity

No two drug development programs are alike - and your CDMO partner should recognize that from the outset. A client-centric CDMO goes beyond offering standard services; it collaborates closely with you to understand the unique scientific, regulatory, and commercial context of your molecule.

Whether it’s adapting formulation strategies for a challenging API, aligning manufacturing approaches with your target market, or navigating region-specific regulatory pathways, a tailored approach is essential to de-risk development and maximize success.

At Aenova, we don’t believe in the one-size-fits-all model. Our teams work closely with clients to understand the unique technical, commercial, and regulatory requirements of each program. Whether you need formulation optimization, alternative dosage forms, or accelerated development timelines, we tailor our approach to your goals.

7. A Culture of Quality and Continuous Improvement

A CDMO with a true culture of quality treats compliance as a baseline and strives for continuous improvement through robust quality systems, data integrity, and proactive deviation management. This includes regular internal audits, real-time analytics, digital quality management systems (QMS), and a commitment to ongoing training across all staff levels.

Look for a CDMO that demonstrates not only strong historical audit performance but also a forward-looking approach to foster a culture of accountability and innovation.

Aenova’s quality systems exceed global standards, and our culture of continuous improvement drives innovation and compliance. Our facilities are regularly audited by customers and authorities, with outstanding results.

Why Aenova?

With over 4,000 employees across 14 manufacturing sites in Europe and the U.S., Aenova is one of the world’s leading CDMOs for pharmaceutical drug product development and commercial manufacturing. Our full-service model, global compliance network, and rich technical expertise and experience enable us to support clients at every step of their development journey.

Ready to move your product forward? Contact us to learn how Aenova can help bring your drug to market – efficiently, reliably, and compliantly.