At Symeres, we support drug development programs with comprehensive stability studies performed in full compliance with ICH guidelines. Stability testing provides the data required to establish product shelf life, define appropriate storage conditions, and meet global regulatory expectations.
We offer both long-term and accelerated stability studies under standard ICH conditions, including:
- 5°C
- 25°C/60% RH
- 30°C/65% RH
- 40°C/75% RH
Selected batches are stored in the agreed packaging configurations within our qualified stability chambers, ensuring controlled and reproducible conditions throughout the study.
To assess product integrity, we apply validated stability-indicating analytical methods to monitor changes in critical quality attributes, including assay, impurity levels, dissolution, and physical properties. These studies provide the robust data necessary to evaluate potential degradation pathways and to demonstrate product quality over time.
With decades of expertise in analytical development and regulatory support, Symeres delivers stability packages tailored to client needs, whether as stand-alone studies or as part of an integrated CMC program. This ensures reliable data for regulatory submissions and a smooth transition toward later clinical phases and eventual commercialization.
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.
