Services - Steer the Right Course with R5
The number of experiments that could be carried out to move from API to product is potentially infinite. The amount of API, time and cash is definitely not infinite. So let R5 help you to navigate through these hazardous waters. Select from the dosage form list.
Preformulation |
During the preformulation phase we will learn about the API; the ways in which it may be and cannot be manipulated. This sets down the potential routes for designing the optimum drug delivery system. We will then assess the potential of specific excipients and potential manufacturing methods to be used with the API. This phase of development is often overlooked yet data generated here provides a firm foundation for all that follows. |
Formulation and Manufacturing |
Our extensive knowledge of pharmaceutical ingredients plus the API preformulation data enables us to suggest the most suitable combinations of materials and manufacturing methods to be used in the prototype stage of development. We possess equipment to produce most dosage forms including tablets, capsules, liquids, suspensions, creams, ointments and sterile pharmaceuticals. At R5 we will manufacture prototype batches of products to conserve your API yet generate valuable data. Once the stability and the performance of the desired product is established we can quickly scale-up to whatever batch sizes are required for clinical use. |
Analytical Chemistry and Stability Testing |
The R5 Analytical Chemistry laboratories provide all the methods and data to assist with the development of the product. Our scientists are equipped with a wide range of tools and techniques to develop, improve and optimise methods.
|
Manufacture of Clinical Trial Materials |
R5 will prepare the required materials for clinical trials to support studies up to Phase 2 manufactured in our cGMP compliant facilities. For studies in Europe an R5 QP (Qualified Person) will release the materials. |
Clinical Packaging and Comparator Supplies |
R5 provides packaging in blisters, bottles, tubes, or vials. Matching placebos are formulated and manufactured for comparator studies. We can obtain commercial stocks of comparators if necessary. |
Regulatory Support |
R5 experts will assist our customers in the preparation of the documentation (e.g. IMPD in Europe) to gain approval for the clinical study to be carried out. |
Technology Transfer |
R5 services extend to helping the next custodian of the development project to be successful. We undertake in all our contracts to provide technology transfer assistance for manufacturing and analytical chemistry as the project moves into Phase 3 and commercial scale. |
