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.
We offer a complete Pharmaceutical Development service, fully integrated with the industrial unit of Medinfar Group, 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:
Solid Products
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Pills
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Capsules
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Pellets
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Powders
Liquid Products
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Solutions
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Suspensions
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Syrups
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Drinkable Ampoules
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Shampoos
Semi-solid Products
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Creams
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Ointments
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Gels
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Emulsions
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Lotions
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Foams
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Mousses
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Suppositories
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Soaps