Reducing program risk with robust quality and regulatory systems
Solvias helps you navigate the complex regulatory and quality landscape. Our robust quality processes and dedicated project management are there every step of the way to ensure your therapeutics meet the highest quality standards and comply with regulatory requirements.
Commitment to quality and compliance
At Solvias, quality is an integral part of our operations. Our robust Quality Management System meets Good Manufacturing Practice (GMP) and ISO 9001:2015 requirements. We are regularly inspected by the relevant authorities including Swissmedic, the ANSM, the FDA and ISO certification authorities. We are committed to delivering reliable and compliant results to our clients.
With several Qualified Persons (QP) in-house, we offer certificate of analysis (CoA) release services and are certified manufacturers (Manufacturing / Importers Authorization (MIA) holders) for quality control of human and investigational medicinal products (IMPs). Solvias has the capabilities to perform GMP batch testing and results release for sterile, non-sterile, and biological medicinal products. Thanks to mutual recognition agreements (MRA), our batch testing activities are suitable for the European Economic Area (EEA) and the US market.
Dedicated project management
Superior project management is a key Solvias advantage. Dedicated project leaders serve as your go-to point of contact throughout our engagement, seamlessly integrating with your team. Their expertise and experience is focused on achieving economical, high-quality, on-time results, while reducing risk. From early drug development stages to post-marketing surveillance, we support and collaborate with you to meet the regulatory requirements at every stage of the drug product lifecycle.
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- Certificate of GMP Compliance, Solvias Basel (2024) View Resource
- ISO 9001:2015 Certification, Solvias Kaiseraugst, Solvias Basel (2024) View Resource
- Certificate of Pharmaceutical Authorization Site, Solvias France (2023) View Resource
- FDA Certificate of Registration, Solvias France (2024) View Resource
- Pharmaceutical Authorization Site ANSES, Solvias France (2023) View Resource
- GMP Compliance for Veterinary Medicinal Products, Solvias France (2023) View Resource
- ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 Certification, Solvias France (EN) (2023) View Resource
- ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 Certification, Solvias France (FR) (2023) View Resource
- ISO 17025: 2017 Accreditation Certificate, Solvias France (2023) View Resource
- ISO 26000: 2010 Certification, Solvias France (2023) View Resource
- Certificate of GMP Compliance for Human Medicinal Products, Solvias France (2023) View Resource
- ISO 17025:2017 Certification, Cergentis B.V. (2022) View Resource
- Certificate of GMP Compliance for Investigational Medicinal Products, Solvias France (2022) View Resource
- Certificate of GMP Compliance, Solvias Kaiseraugst (2022) View Resource
- FDA EIR, Solvias France (2014) View Resource
