As the Pharmaceutical Industry prepares for the patent cliff, many companies are trying to rationalize their resources and to focus on the most important products in their pipeline. Some companies may not have in-house regulatory expertise. Where the workload reaches overcapacity or requires expertise that is not available “in-house”, Redstone Health Group will be pleased to provide customized expertise and resources as necessary to meet your specific needs.
Redstone Health Group is able to offer support for ‘mainstream’ Clinical Trial Applications, New Drug Submissions, and Supplemental submissions. We can provide supplemental resource, planning expertise or manage the entire process of submission compilation to submission negotiation for approval.
We are also able to manage the smaller submissions such as Drug Identification Number, and Certification of Pharmaceutical Product (required in foreign markets). These submissions are often seen as less ‘important’ compared with the pipeline submissions and yet, can be critical to the availability of new products.