Process Development & Analytical Development Services

Comprehensive Process Development Expertise

At Veranova, our phase-appropriate solutions are tailor-made to meet the unique demands of each API. By developing a synthetic route that is safe, economical, scalable, and aligned with green chemistry principles, we provide a streamlined route to market.

Our capabilities include:

Process safety assessments
Process characterization
Expedited development, including statistical design of experiments (DOE), catalytic screening, and the development of processes suitable for larger-scale operations
Purification techniques, including crystallization and chromatography.

“Antiva is a small biopharma that relies on external CDMO partners for the development of a labile prodrug with unique technical challenges. So it is critical for Antiva to have a partner we can trust to be our ‘eyes and ears’ on the floor, manage near term objectives and not lose sight of long term goals.

Veranova truly stood out for their ability to take full ownership of a program. They are nimble, collaborative and maintain a transparent dialogue regardless of the challenge at hand. Their top-notch teams are not only engaged, but are great at managing bottlenecks in resources, facilities, supplies etc., and when needed proactively pushed us to ensure the program’s success. I am thrilled to be working with Veranova on this program.”

– Antiva Biosciences

Process development

Our scientists and engineers develop synthetic processes to enable rapid, phase-appropriate product development and commercialization.

Analytical method development

Our dedicated team of experts and extensive equipment capabilities enable us to deliver quality analytical methods throughout all phases of clinical development, GMP scale up and commercialization in line with ICH and FDA/MHRA/EMEA requirements.

Analytical Method Development and GMP Readiness

In parallel, our analytical method development team aims to ensure all methods meet project requirements and GMP-readiness. Leveraging experience with method transfer, development, optimization, qualification and validation, we offer a wide range of characterization techniques. These include:

Characterization of APIs and precursors
Elemental impurity risk assessments
Impurity isolation, identification and characterization

Meanwhile, our complete analytical suite comprises capabilities in UPLC & HPLC (UV-Vis, CAD and MS detectors), GC and GC-MS, NMR LC-MS, and solid-state characterization.

Regulatory and Quality Excellence

Quality, compliance and regulatory affairs are imperative to the life cycle of a drug, from development to commercialization. As such, we provide extensive support with analytical testing requirements. With expertise in over 40 markets including the United States, Canada, United Kingdom, European Union, China, Brazil, South Korea and Japan, our global analytical team supports alignment with regulatory expectations across clinical phases.

Integrated Project Management

At Veranova, project management is the basis of a true partnership throughout the drug commercialization journey. Our project management team collaborates closely with clients to develop customized, strategic plans tailored to specific program needs. This collaborative approach helps navigate challenges, align priorities, and maintain project momentum. Through integrated project management across technical, quality, and operational teams, Veranova fosters transparency and agility — enabling timely, confident delivery of APIs to market.

Find out more about Veranova’s values here

Facilitating Seamless Technology Transfer

At Veranova, we understand the importance of technology transfer throughout drug development and production. Our approach begins with prescreening activities such as technical review, equipment availability, and safety assessments. Then, process and analytical teams review the process chemistry, feasibility at each site, RSM/RM material, specifications, and impurity limits. The workflow continues through project management, manufacturing, and quality and regulatory affairs, ensuring that all technical, operational, and compliance aspects are addressed to allow a successful transfer to one of our GMP manufacturing sites or another facility.

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Process and Analytical Development