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Laboratory Development
Well-grounded technical decisions from the start
We design and optimize laboratory-scale processes with analytical support from the earliest stages, ensuring control, reproducibility, and a solid foundation for scale-up.
Your strategic partner in research, development, and quality control services. At PILOT OSSA, we work alongside regulated companies to address technical challenges from project conception through the final stage of commercialization, supported by strong human, scientific, and regulatory expertise.
From concept to certified products, we deliver chemical and analytical services designed to adapt to the technical and regulatory needs of each project.
Reliability, performance, and compliance throughout the method lifecycle
We develop, validate, and optimize analytical methods tailored to the matrix and target analyte, ensuring robust and reproducible results over time.
Method development and validation / verification
Method optimization and comparability
Analytical transfer and performance assessment
Scientific evidence to support product shelf life and safety
We design and manage stability studies in accordance with ICH and NOM guidelines, generating reliable data to support regulatory and commercial decision-making.
Comprehensive study design and management
Stability-indicating methods and validation
Rental of climatic chambers
Microbiological safety for critical areas and non-sterile products
We provide comprehensive microbiological control solutions aligned with Good Manufacturing Practices (GMP) and current health regulations.
Sanitization and disinfection programs
Minimum Inhibitory Concentration (MIC)
Microbial limits testing (MGA 0571)
Control, consistency, and regulatory compliance
We perform compendial physicochemical testing for raw materials, intermediates, and finished products, ensuring quality and regulatory compliance.
Karl Fischer, volumetric analysis, and chromatography
Volatile organic impurities, COD, and color
Water and alcoholic beverage analysis
Applied innovation, scalable and market-driven
Our R&D approach integrates synthesis, formulation, and scale-up to transform ideas into viable, efficient, and sustainable manufacturing processes.
Custom synthesis and compound manufacturing
Impurities, related substances, and formulations
Technology transfer and scale-up
We operate as a Contract Research, Development, and Manufacturing Organization (CRDMO), integrating into our clients’ projects from development through commercial manufacturing, with a comprehensive focus on quality, scalability, and regulatory compliance.
Laboratory Development
We design and optimize laboratory-scale processes with analytical support from the earliest stages, ensuring control, reproducibility, and a solid foundation for scale-up.
Pilot Plant
We validate and optimize processes in pilot-plant operations (50–100 gallons), mitigating technical and operational risks ahead of commercial scale-up while maintaining consistency, quality, and efficiency.
Commercial Plant
We design processes with full analytical support at every manufacturing stage, ensuring controlled technology transfer to commercial-scale facilities (1,000–3,000 gallons), with comprehensive in-process and final product control.
Compliance that opens markets
Our facility operates under cGMP standards, with ISO 8 cleanrooms and successful audits by international regulatory agencies such as the FDA and PMDA, enabling access to highly regulated markets.
Long-term vision
We collaborate in the design of processes that reduce emissions and effluents, promoting safer, more efficient, and more sustainable chemistry throughout the entire production lifecycle.
We don’t operate as an isolated laboratory. We act as Full Cycle Partners, integrating into every critical stage of your product’s lifecycle to ensure performance, compliance, and scalability.
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Gas and liquid chromatography (GC, HPLC, GC-HS)
FTIR and UV-Vis spectroscopy
Climate chambers for stability studies
Physicochemical measurements (pH and conductivity)
Quantitative Karl Fischer determination and Analytical balances
Instruments fully qualified and periodically calibrated
Our services are aligned with the Mexican Standards Catalog (NOM and NMX), supporting compliance with COFEPRIS, SEMARNAT, and international regulatory authorities, enabling access to regulated markets with robust technical and documentary backing.
