Why work with us?
Whether you need extra capacity during workload peaks or specific, dedicated expertise, NovoSere provides flexible and scalable support. From tech to trial.
We prepare scenarios and create risk-based roadmaps to help make informed decisions. We select strategic partners and manage the CMC program.
Knowledge experts
Boost your program with 4 PhDs with specialized industrial expertise in DS,
DP, AMD and CMC Strategy.
Integral team
Tap into collective intelligence and diverse capabilities in ways isolated experts cannot match.
Committed
Extend your team with NovoSere as your committed and constant CMC partner.
CMC Strategic Support
NovoSere provides specialized Chemistry, Manufacturing, and Control (CMC) strategic support designed to bridge the gap between drug discovery and clinical success.
By offering an integrated team of experts, they help biotech innovators navigate the complexities of process development, formulation, and regulatory compliance.
Technical Guidance
NovoSere’s Technical Guidance transforms complex scientific challenges into an industry-aligned manufacturing processes.
We provide deep expertise in analytical development, formulation development, process development, process characterization, and scale-up, ensuring your product remains stable and reproducible. By solving technical hurdles before they become regulatory roadblocks, NovoSere maintains the integrity and safety of your therapeutic asset.
Outsourcing & Support
NovoSere optimizes the transition from lab to clinic by aligning outsourcing strategies with high-level technical support.
We provide expert oversight for CDMO selection and management, ensuring partners meet rigorous quality and timeline goals. Our technical guidance de-risks the process, providing the precision needed to turn complex science into scalable reality.
GMP Support
NovoSere provides regulatory‑driven GMP support, and writing of IMPD/IND quality sections, to ensure compliance without unnecessary complexity. We design and execute GMP and documentation activities in a phase‑appropriate manner, aligned with regulatory expectations for each stage of development.
Our strength lies in knowing what is required, when—and just as importantly, what is not—so effort and cost are invested where they add real value. By applying a risk‑based CMC strategy, we enable efficient clinical progression while safeguarding future regulatory and lifecycle success.
Let’s work together
Whether you are navigating early-stage tech transfer or applying for marketing authorization, NovoSere is here to drive your next milestone. We provide real-world CMC guidance and clear, risk-based strategies that deliver measurable impact, eliminating guesswork and technical overwhelm.
