Technical Services

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.

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.

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