Expert statements, overviews and summaries

Non-clinical and Clinical

AccepTher has an active experience of preparing the clinical and non-clinical documentation for all types of applications.

For "abridged" products (i.e. generics, "hybrids") or bibliographical the non-clinical and clinical overviews mainly rely on published literature, which comes to round-up the critical review of the "simplified" clinical development programme, usually consisting of bioequivalence studies.

When preparing such overviews, our experts use reliable scientific databases in order to identify key studies published, which are assessed against the Summary of Product Characteristics of the reference product. The result is an annotated SmPC, which is further useful for our clients when positioning and/or developing the promotional campaign for their products, if branded.

Quality

AccepTher has the active experience in preparing and maintaining the Quality documentation of innovative and „abridged” products.