Regulatory Solutions

Our Regulatory Solutions group provides software and services for converting, managing, storing, sharing and submitting information to FDA, EMA and other agencies.

Instem’s submit™ platform provides a suite of integrated tools and services for the creation and management of SEND (Standard for Exchange of Nonclinical Data) datasets for Contract Research Organisations (CROs) and Sponsors.

On December 17, 2016 the FDA SEND Mandate for providing regulatory submissions in electronic format came into force. The SEND format enables more efficient review of nonclinical data, offering improved data quality, accessibility and predictability. The standard itself has been designed to provide a vehicle for more easily transporting to regulators the results of the majority of standard regulatory toxicology studies. Failure to comply with the Mandate can result in the FDA’s technical rejection or refusal to file a submission, therefore, it is vitally important that organisations are SEND compliant.

The introduction of SEND for both regulatory submission and the electronic exchange of toxicology data is having a significant impact on the industry. Each organisation in the pharmaceutical early development value chain is now touched by the implementation of this standard and has to make changes to their systems and working practices.

Instem has stood shoulder-to-shoulder with our partners in the pharmaceutical, contract research and regulatory communities to invest time and money in the creation of SEND since its inception, working closely with SEND pilot organisations and the FDA to help define the standard and align it with industry practices. We are proud to have worked with some of the brightest and most dedicated individuals to help create the SEND standard.

Instem’s submit suite of tools and outsourced services is now the most widely adopted SEND solution in the market across 15 countries.