Non-Routine Analytical Studies in Support of Regulatory Submissions

Analyses used to Support Regulatory Submissions

Work performed at Selcia has been used to support customers’ regulatory submissions both formally through GLP studies and informally by providing metabolite / impurity identification / profiling methodology and information so that the customer can perform the required analysis in-house under regulatory conditions.

Formal Analysis via GLP / GMP Studies

The majority of the GLP analyses performed at Selcia are certifications of test items that are used in customer studies which are subsequently used in the customer’s regulatory submissions.

We have also performed studies such as metabolite identification, storage stability and impurity profiling which are included as part of a wider package within customers’ regulatory submissions.

14C radiolabelled API GMP preparation and analysis at Selcia is typically performed to support customers’ phase I clinical trials.

Informal Analysis

We have performed numerous informal studies (rather than full studies under regulatory conditions) where we have provided identity information for unknown peaks in samples. The customer has then subsequently taken the unknown impurity / metabolite information and used this to formally identify the peaks within their own studies. The customer has then used their own studies / data to support their own regulatory submissions.