Pharmaceutical Development Lab Services
FromMedinfar Group
We have a highly qualified and committed team, which is concerned with the development and reformulation of solid, semi-solid and non-sterile liquid products, as well as manufacturing processes in accordance with regulatory requirements to submit the respective dossiers to the competent authorities.
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We offer a complete Pharmaceutical Development service, fully integrated with the industrial unit of Medinfar Group - Farmalabor, which includes:
Pre-formulation
- Bibliographic research, regulations and applicable guidelines
- Study of the general API properties
- Analysis of excipients and their API compatibility
- Evaluation of primary packaging materials and their selection
- Preparation of a pre-formulation and "outline" of a manufacturing process
- Others
Formulation and Development of Projects
- Implementation of the pharmaceutical development trial phase, through laboratory tests and identification of critical steps in the manufacturing process
- Others
Formulation Optimization
- Reformulation and continuous optimisation of pharmaceutical formulations in accordance with the latest regulations and legislation in force (prohibited substances, new maximum permissible limits/restrictions...)
Scale Up and Technology Transfer Integrated With the Industrial Unit
- Pilot / industrial scale-up
- Preparation of manufacturing instructions
- Monitoring of the manufacture of pilot / industrial batches
- Others
- This whole process allows for the generation of data and documentation, crucial for the preparation of Module 3 of the MAA (Marketing Authorization Application) dossier, which (together with the other modules) enables its subsequent submission to the competent authorities.
- All these activities are developed by considering regulatory and quality requirements. Thus, we are able to cater for national and international market needs.
- We develop and reformulate a wide range of products, such as: