Formulation development
We have a full spectrum technical services from an early-stage development to registration batches, in every step quality and regulatory conformity will be monitored, to ensure acceptability of the regulatory filling to health authorities.
By applying the principles of Quality by Design ( QbD ), our cross-functional team of experts in pharmaceutical industry focuses on the identification and understanding of the parameters that can affect the critical quality attributes. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls.
We offer a competitive development environment to virtual and start up companies.
Analytical services
Our team of experienced academics have the knowledge and the competence to develop, validate the analytical methods, perform the analysis and deliver the results by email or in the form of a certificate of analysis. We are at your disposal to carry out any analysis or method development that you choose to entrust to us. We offer to our clients over 20 years expertise on method development and analytical services for Pharmaceutical and nutraceutical industry.
Development/Optimisation/Troubleshooting/investigation/Validation/ Transfer Analytical House Methods and monograph Methods (USP, FCC, BP, EP and JP) for both raw materials and Finished Products.
Animal feed and nutritional supplements testing including Vitamins, Amino acids, Essential Oils.
Establish Dissolution conditions during the formulation process
Assay Stability-Indicating· Impurities/Degradation products· Forced degradation study· Stability studies
Residuals solvents/Organic Volatiles Impurities
Reverse Engineering
Scientific advice and support for your Clarifax
Review and Assessment of Active Pharmaceutical Ingredient (API) Drug Master Files (DMF)
Regulatory Affairs
We are offering a services related to pre-approval and post-approval activities
Regulatory strategy adapted to the product development
Regulatory consulting and intelligence
Strategic regulatory advice
Investigational filings and clinical trial applications
Regulatory dossier compilation, review and publishing
Market authorization filings and management
Post-approval lifecycle management
Electronic Common Technical Document (eCTD) Preparation and submission .
Technology transfer
Our team has extensive experience in process improvement and technology transfer, focusing on the robustness and quality. The technology transfer process includes the following activities :
Risk analysis related to the introduction of a new product .
Health and Safety Assessment .
Transfer or purchase of equipment .
Installation, operation and performance qualification of the equipment.
Staff training and commissioning of the equipment.
Manufacturing of engineering batches for the process transfer
Manufacturing of validation batches in the receiving site.