Our Services – Pharmaceuticals & Veterinary Medicine
Storage stability solutions
Storage Stability Solutions in Healthcare and Veterinary Care
Ensuring that pharmaceuticals, healthcare products and veterinary medicines maintain their efficacy, safety, and quality during their shelf life is fundamental to patient health and well-being. CEMAS offers comprehensive storage stability solutions designed to meet regulatory requirements and industry standards.
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Our Services
Stability Testing
- Accelerated Stability Testing: Simulates extreme conditions to predict long-term stability.
- Long-term Stability Testing: Monitors the product under recommended storage conditions over its expected shelf life.
- Intermediate Stability Testing: Assesses the product’s stability under moderately stressful conditions.
Environmental Monitoring
- Temperature and Humidity Control: Advanced systems to maintain optimal storage conditions.
- Photostability: Evaluates the impact of light on product stability.
Regulatory Compliance
- ICH and VICH Guidelines Adherence: Our processes comply with International Council for Harmonisation and the Veterinary International Conference on Harmonisation (ICH and VICH) guidelines.
- GMP Compliance: Our facilities and procedures meet Good Manufacturing Practices standards.
- Documentation and Reporting: Comprehensive documentation to support regulatory submissions.
Custom Solutions
- Tailored Stability Programs: We offer a customer-centric approach, with customised testing protocols to meet specific product needs.
Storage Facilities
Our facilities offer a comprehensive range of continuously monitored, controlled storage, with 24-hour alarm systems and dedicated on-call teams. Stability storage conditions include:
- Frozen Storage of -80°C and -20°C
- Refrigerated Storage of 2-5°C
- Ambient Storage at 25°C/60%RH
- Custom conditions to meet specific regulatory requirements, including 30°C/65%RH
- Accelerated stability storage, including 30°C/75%RH and 40°C/75%RH
Our testing protocols include:
- Accelerated Stability Studies
- Long-term Stability Studies
- Intermediate Stability Studies
- Photostability Testing
CEMAS also provides a full suite of physical testing and chemical analysis services following storage to support the regulatory approval of your products. Our advanced instrumentation and extensive capabilities enable us to thoroughly assess product stability, ensuring compliance with industry standards and regulatory requirements – Find out more
Why choose CEMAS?
Science
Our scientists and study directors bring decades of experience and expertise
Compliance
GLP, GCP and GMP compliance to ensure that your regulatory needs are met
Delivery
Flexibility and responsiveness to your requirements, to provide quality data on time
Reliability
Quality and delivery are at the heart of all we do
