By continuing to access the site you are agreeing to their use. Learn more about cookies. hamburger-icon Menu What We Do Formulation Development We devise and implement product specific development strategies capable of delivering high-quality formulations and robust manufacturing processes. To achieve our clients’ goal, several studies are performed as a means of achieving deliverables assigned to certain distinct development phases: Preformulation phase: Analysis of bibliographic data, review of existing patents investigation of the most relevant physicochemical properties of the candidate drug substances. Formulation development phase: Screening and optimisation studies, varying in nature depending on project’s particular characteristics, provide the necessary level of information for the provision of the optimum composition. Throughout the development phase, contemporary approaches, aligned with the latest ICH recommendations; including the adoption of Quality by Design (QbD)-oriented principles and tools (e.g. statistical experimental design and risk assessment techniques) are implemented for building up the respective development programmes. Development of analytical methods is integral part of this phase. Process development phase: Screening and optimization process activities, challenging critical process parameters, give rise to robust and transferable processes. The availability of state-of-the-art equipment, fully representative of and simulating that of industrial scale offers large flexibility in the selection of CMOs, facilitating ultimately the smooth transition from R&D to production scale. Scale-up (technology and site transfer activities): Scale-up tasks are effectively undertaken by our skilled team, contributing to the minimizing of tech-transfer risks. Key areas of expertise Immediate/modified release dosage forms Tablets Capsules Solutions Suspensions Powders for reconstitution Topical dosage forms Creams Ointments Cutaneous solutions Sterile dosage forms Injectables Nasal preparations Ophthalmic preparations Other Services Analytical Our state-of-the-art laboratories offer a wide range of analytical services to support your exact needs under strict quality procedures which meet GMP requirements and following ICH guidelines. Analytical Clinical Development In applications for Generic and Generic Plus medicinal products, the concept of bioequivalence is fundamental. Clinical Development Regulatory Continuous evolution in science and changes in the regulatory environment and health sector, creates the need for professional regulatory guidance throughout the lifecycle of a healthcare product. Regulatory OUR OFFICE Lamda Laboratories S.A. 59, Ioannou Metaxa str 19441 Koropi Greece SITE TOOLS Stay in Touch About us Careers Contact Us Terms of Use Sitemap Privacy Policy Modern Slavery Statement CONTACT US Contact us for more information T: +30 210 3232 789 F: +30 210 6643 850 E: info@lamdalabs.eu © Copyright 2021 Lamda laboratories By Emperor