An experienced team to take your route to the next level
Make use of our 30 years’ experience and collective brainpower to design the optimal route towards your new drug. Furthermore, the process can seamlessly transition to our scale-up non-GMP or GMP units.
We offer an integrated approach to process development to achieve a comprehensive control strategy and ensure that the chemistry developed is readily and safely scalable in a manufacturing environment. Our development approach aims at delivering a manufacturing route that satisfies operational performance requirements and those of the regulatory authorities.
With two separate non-GMP and cGMP supporting business units, key preclinical milestones can be reached quickly, without the GMP overhead. We ensure a seamless transition into our GMP operation for clinical API manufacturing. This is a highly efficient and cost-competitive model, whereby you can always count on an experienced support team with a dedicated project manager.
Developability Roadmap
Streamline the path from discovery to development with a clear, data-driven plan to evaluate risks and guide your IND/IMPD filing.
Process Research and Development
Design robust, scalable routes with risk assessments, catalyst screens, and DoE optimization to ensure reliable clinical supply.
Non-GMP Scale-Up for IND-Enabling Studies
Bridge discovery and development with efficient non-GMP scale-up, delivering well-documented processes that minimize cost and risk.
GMP Manufacturing
Achieve right-first-time GMP scale-up with reliable process development, full analytical support, and strict quality and safety controls.
GMP Starting Materials
Secure reliable, high-quality starting materials with Symeres’ large-scale non-GMP facilities and regulatory expertise.
Solid-State Chemistry and Pre-Formulation Research
Select the optimal solid form and formulation to improve stability, solubility, and bioavailability early in development.
Formulation Development and Clinical Manufacturing
Advance through preclinical to Phase 3 with tailored formulations, GMP clinical supply, and regulatory dossier support.
Analytical Development Services
Ensure product quality and compliance with comprehensive method development, impurity profiling, and GMP stability testing.
ICH Stability Studies
Establish shelf life and storage conditions with ICH-compliant long-term and accelerated stability studies.
Quality Unit
Rely on Symeres’ GMP-certified quality systems, QA/QC expertise, and FDA-inspected facilities to ensure compliance.
EHS Compliance
Protect patients, employees, and the environment with rigorous EHS evaluation of all incoming materials and projects.
