Medium Pharma Companies
Medium size pharma companies can require the entire spectrum of services provide by R5 for new dosage form development. Alternatively you may have your own facilities but be overwhelmed by the requirement for clinical trials materials, stability testing or the development of new formulations for existing APIs (i.e. Product Life Cycle management)
New Formulations of Existing APIs
R5 is an ideal source of your new formulation. Our expertise across most dosage forms means that no matter what you require we are ideally placed to deliver it, and deliver it quickly. Our contracts are simple to understand and you own 100% of the new product.
Manufacture of Clinical Trial Materials
At R5 we can react quickly and put the administration in place to accommodate your clinical trial needs. This can be in any of the dosage forms including oral, topical and sterile.
We will create the commercial agreement quickly and work with your technical/quality agreement and confidentiality paperwork. It may be faster to obtain all the ingredients for the dosage form from you , although we can obtain them ourselves if required. We will require TSE certificates and supplier source details in oder to facilitate a rapid appraisal by our QA group and QP
Manufacture will be carried out by our staff under GMP.
Testing can also be carried out at R5 although it is acceptable for testing to be retained by our customer in some of these situations.
Products will be released by our QP to pre agreed specifications.
We will work rapidly and proactively to help you meet your clinical trial deadlines.
Stability Testing
Our Analytical Chemistry labs are at your disposal to relieve you of the management , sample storage, sample testing and reporting of stability data. Our expertise across most dosage forms means that we are ideally placed to transfer your analytical methodology and provide you with a cost effective and efficient service.