The development of a drug is a complex process that goes far beyond simple manufacturing. It encompasses scientific research, formulation development, clinical trials, industrial production, and regulatory compliance.
To support these different stages, pharmaceutical companies can rely on specialized service providers, each bringing specific expertise: Contract Research Organization (CRO), Contract Development Organization (CDO), Contract Manufacturing Organization (CMO), and Contract Development & Manufacturing Organization (CDMO).
To help you identify the provider best suited to your project, here is an overview of each of them:
Contract Development Organizations (CDOs) are primarily involved upstream of industrial development, transforming a scientific idea into a robust and reliable pharmaceutical product. Their expertise includes formulation optimization, stability and bioavailability assessment, and preparation for industrial production.
CDOs also ensure that the formulation can be efficiently transferred to manufacturing sites, taking into account technical and regulatory constraints. This step helps reduce technical risks, optimize pharmaceutical formulation development, and save time before moving on to larger-scale production.
For example, in the development of a transdermal patch, a CDO will test different formulations of the matrix and adhesive to ensure controlled and stable release of the active ingredient over the intended duration. They conduct in vitro permeation studies on skin models to quantify the amount of active ingredient passing through the skin per unit of time, thereby optimizing the patch's performance. The CDO then prepares pilot batches in accordance with Good Manufacturing Practices (GMP), which are used in clinical trials to verify efficacy, tolerability, and reproducibility of the formulation.
Contract Research Organizations (CROs) specialize in research and the conduct of preclinical and clinical trials. They support pharmaceutical companies at every stage of the studies, from protocol design to data analysis, including rigorous patient monitoring and the management of adverse events.
Thanks to their expertise, CROs ensure regulatory compliance, data quality and reliability, while guaranteeing participant safety. Working with a CRO allows companies to outsource the scientific validation of their drug candidates and benefit from the experience of seasoned professionals across clinical phases I to IV. It also helps reduce timelines and risks while ensuring that the data collected are solid and usable for market authorization.
For example, in a clinical trial for a new transdermal patch, the CRO begins by designing an adapted protocol, defining the dose, application frequency, and patient monitoring criteria. Clinical monitors then ensure that each center adheres to the protocol and that patients apply the patch correctly, while documenting any cutaneous or systemic adverse effects. Data managers collect and verify the information to ensure that the data are reliable and usable. Finally, statisticians analyze these data to evaluate the efficacy and tolerability of the patch, in order to determine whether the product can proceed to subsequent phases and ultimately reach the market.
Contract Manufacturing Organizations (CMOs) focus on the industrial production of pharmaceuticals. They operate GMP-certified facilities to manufacture clinical or commercial batches, allowing pharmaceutical companies to access production capacity without investing in their own infrastructure.
CMOs also offer the ability to adapt production to project needs, whether small batches for clinical trials or larger volumes for the market, and they ensure supply continuity through well-controlled processes and high quality standards. They are particularly valuable for the production of stable, complex, or sensitive products, where manufacturing control is crucial for ensuring drug safety and efficacy.
For example, in the manufacturing of a transdermal patch, the CMO takes the formulation developed by the CDO and produces it in industrial-scale batches. It ensures that each patch contains the exact amount of active ingredient, that the adhesive and matrix are uniform, and that the drug release remains consistent from batch to batch. The CMO also performs quality control tests on each batch (stability, uniformity, adhesion, and absence of contamination) before the product is used in clinical trials or brought to market.
Contract Development & Manufacturing Organizations (CDMOs) combine both development and manufacturing expertise to support a pharmaceutical project from initial design to commercial product. They can contribute to formulation, process optimization, industrial scale-up, and the production of clinical and commercial batches, providing an integrated workflow that minimizes technology transfers between providers and shortens time-to-market.
CDMOs also bring expertise in managing complex formulations or sensitive Active Pharmaceutical Ingredient (API), while ensuring regulatory compliance and product quality. This comprehensive approach allows companies to benefit from a single partner capable of securing the entire project, optimizing resources, and facilitating coordination between development and manufacturing.
For example, in a transdermal patch project, a CDMO can handle the formulation optimization, produce pilot batches compliant with Good Manufacturing Practices (GMP), and manage industrial scale-up, thereby allowing the laboratory to move quickly from clinical trials to commercial production, while ensuring that the product meets quality and stability standards.
With over 40 years of experience, AdhexPharma is a leading French CDMO specializing in transdermal patches and oral films. We support our pharmaceutical partners at every stage of their project, from idea to market, offering unique expertise that combines complex formulation development, process optimization, technology transfer, and GMP manufacturing.
Our German R&D excellence center, Labtec in Langenfeld, has extensive experience in formulating oral films and transdermal patches. It is equipped to perform in-house permeation studies on human skin and porcine mucosa (esophageal or buccal), providing reliable data to reduce technical risks and enhance formulation precision before clinical trials or bioequivalence studies.
A key strength of ours is the integrated workflow between development and manufacturing. Our teams work closely to ensure that each R&D-optimized formulation is effectively transferred to GMP production, guaranteeing quality and product reproducibility. Our facilities are also designed to handle highly potent APIs and hormones, including narcotics, corticosteroids, and other highly potent molecules.
This combination of expertise and technical capabilities makes AdhexPharma a comprehensive partner, capable of managing the entire pharmaceutical development process, from concept to commercial product. Beyond development and manufacturing, our analytical expertise allows us to support every project with rigor and precision, ensuring high-quality, safe products perfectly suited to patient needs. This integrated approach ensures continuous oversight and optimization at every stage, minimizing technical risks and accelerating time-to-market.
The choice between CROs, CDOs, CMOs, and CDMOs depends on the development stage of your project and the services required. CROs provide scientific and regulatory expertise for clinical trials, CDOs ensure formulation robustness and technical feasibility, and CMOs guarantee reliable GMP production. CDMOs combine development and manufacturing to offer an integrated support, which can simplify project management, reduce risks, and accelerate time-to-market.