Routine Testing
Services (GMP).
Request a QUOTE
Gracias a nuestro entorno conforme a las BPF y a nuestro demostrado conocimiento científico, así como a nuestro moderno equipo de laboratorio, podemos ofrecer servicios de primera clase que cumplen completamente con la normativa. Como planta inspeccionada por la FDA de los EE. UU. y establecimiento farmacéutico certificado con una persona calificada, puede confiar y contar con nuestros servicios de ensayo rutinario.
Lanzamiento de lotes
clínicos y comerciales
Lanzamiento de lotes
clínicos y comerciales
Pruebas de sus lotes clínicos y comerciales con análisis completos para los mercados de la Unión Europea (UE) y Estados Unidos.
Análisis
de CC
Análisis
de CC
¿Tiene que lidiar con falta de formación o busca un socio fiable para realizar algunos de sus ensayos rutinarios?
Estudios
de estabilidad
Estudios
de estabilidad
Almacenamiento de las muestras en condiciones controladas en cámaras climáticas y realización de pruebas de estabilidad.
Bioequivalencia (BE)
in vitro
Bioequivalencia (BE)
in vitro
Estudios y ensayos comparativos conformes a las directrices de la FDA y USP <1090> con el fin de obtener una bioexención para sus productos genéricos.
Validación de método
analítico y transferencia
Validación de método
analítico y transferencia
Documentación conforme a las BPF para diferentes métodos con método escrito, protocolo aprobado e informes de validación o transferencia.
QC Analysis
Outsource your routine testing for various types of tests and different analytical techniques. Our FDA-inspected and GMP certified laboratories allow you to efficiently allocate available capacities to mission-critical tasks, deal with staffing shortages, manage seasonal peaks, and avoid investments in costly equipment that is not regularly used.
- DISSOLUTION / IVRT: Manual or automated dissolution tests performed and protocolled according to your validated method by our GMP-certified laboratory.
- ASSAY, DEGRADATION PRODUCTS, AND CU: Content testing according to your validated method. Professional sample management, test execution, and documentation.
- ANALYTICAL METHODS: Use our capacities and expertise for performing routine analysis with your analytical method (LC, UV-Vis, IC, GC with head space).
- PHYSICAL TESTING: Outsource your physical tests such as capsule disintegration time, uniformity of mass, tablet breaking force (hardness), friability, dimensional measurements, or powder characterization.
- LC-MS TESTING FOR IMPURITIES / NITROSAMINES: Documented proof for the absence of carcinogenic impurities in your finished product with our LC-MS testing service.
How to de-risk Nitrosamines detection?
NDSRIs (Nitrosamine Drug Substance-Related Impurities) are a subgroup of nitrosamine impurities that share structural similarities with the active pharmaceutical ingredient (API) in drug products, making them particularly challenging to detect. Their detection requires specific analytical methods, typically LC-MS, which must be developed, optimized, and validated.
We assist our clients with nitrosamine detection through the following services:
- Conducting method feasibility studies, if required
- Developing methods tailored to specific products, with ready methods available for quantifying seven types of NDMA impurities
- Optimizing methods as needed
- Validating methods in compliance with GMP standards
- Performing testing using appropriate analytical methods (LC-MS, GC-MS, or others)
For NDSRI testing, we develop separate, product-specific methods.