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At Unolab, as Global CDMO, we offer fully integrated Research & Development services, with a strong focus on sterile liquid formulations in unit-dose containers for ophthalmic and respiratory applications within others, based on Blow-Fill-Seal technologies.
With over two decades of experience, we support our partners from the earliest concept stages through to commercial manufacturing — applying a Quality by Design (QbD) approach, GMP standards, and a commitment to operational excellence. Our R&D capabilities combine scientific know-how, flexible pilot infrastructure, and multidisciplinary teams to deliver high-performance, scalable solutions guided by a management of the project by our PMO team:
CDMO Full-Service Development Capabilities
Formulation development, including preservative-free options and BFS compatibility
Design, lab development and scale-up of manufacturing processes
Analytical method development and validation (including for analytical methods for assay, related substances and microbiology testing)
Compatibility studies between APIs, excipients and packaging
Reverse engineering, toxicology assessment and patent review (when applicable)
ICH stability studies and stress testing
Clinical and registration batch supply
Technical documentation and regulatory support, including IMPD, technical dossier, eCTD, and BE study
Analytical & Regulatory Excellence
Our dedicated analytical experts ensure continuous quality control throughout the development process. Services include:
Analytical method development, transfer and validation
Extractables & Leachables studies
Cleaning and microbiological methods validation
ICH studies storage and stability testing
