At Symeres, we offer comprehensive analytical development services, ensuring a deep understanding of product quality and stability throughout the drug development lifecycle. With expertise in chromatography, impurity profiling, and solid-state characterization, our GMP-compliant laboratories provide tailored solutions for every phase of drug development
Our services include:
- Method development, optimization, and validation in accordance with ICH guidelines.
- Impurity identification and control strategies, including genotoxic and nitrosamine impurities.
- Full analytical support for APIs and drug products, including (chiral) HPLC/UPLC, LC/MS, NMR, and more.
- Stability studies, dissolution testing, and quality control for regulatory submissions.
We ensure data integrity through advanced informatics systems, offering seamless analytical data management and GMP sample handling. Our team delivers reliable, high-quality analytical packages to meet your drug development needs efficiently and effectively.
Discover Exemplify
We deliver a number of services in partnership with Exemplify BioPharma, a global Partnership Research Organization (PRO) offering end-to-end CMC solutions under one roof.
Exemplify offers:
- Integrated project management across Process Chemistry, Analytical Chemistry, and Formulation Development
- Expert oversight on CRO/CMO selection, contracting, and management
- Comprehensive support with CMC regulatory submissions (IND, IMPD, NDA, MAA)
- Full Quality Assurance and compliance sign-off
- Efficient timeline and budget management
Their newly expanded Formulation Suite also opens the door to enhanced formulation capabilities, strengthening support from early development through to commercialization.
