Regulatory Services

SanaClis remains your trusted partner for all international and local regulatory requirements applicable to your project, providing in-house regulatory support for clinical trials and helping sponsors navigate submissions and country-specific requirements to support study success.

Our Regulatory department is comprised and lead by renowned regulatory figures, whom having previously held senior board level positions within international regulatory bodies, such as the EMA and the FDA.

The dedicated regulatory team work in close cooperation with each sponsor to achieve full adherence to local and regional regulatory requirements, including expert counsel on all Supply Chain regulatory considerations, such as local labelling requirements, etc.

Initial submission strategy
Submission of substantial, non-substantial amendments and notifications
Definition of the submission requirements for each Regulatory Authority (RA) and Ethics Committee (EC) including timelines and any applicable fees
Specification of project deliverables including timing, roles and responsibilities, and resources
Identification of applicable clinical trial regulations and regulatory standards for each proposed study country
Preparation of the whole submission package/dossier & QC
Submission of the dossier via the Clinical Trial Information System (CTIS)

Preparation of required country-specific regulatory documents
Preparation of harmonized submission dossier via CTIS in EU countries
Flexible support in different CTIS roles, based on sponsor needs
Management of Request of Information (RFI) received via CTIS
Labelling preparation including master label text, country-specific label text, translations and review
Global support with local regulatory and labelling intelligence - early engagement with sponsors internal departments to ensure appropriate planning inclusions within IMPD submissions
Advisory and full adherence to local regulatory/labelling requirements, for centrally and locally sourced products

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Streamlined Regulatory Pathways

Regulatory and regulatory-scientific affairs in the clinical trials sphere are rapidly changing, mainly in the context of several regulations and many recent guidelines that have been implemented by various regulatory bodies.

The SanaClis Regulatory department provides management of Clinical Trial Application (CTA) submissions to Regulatory Authorities, Ethic Committees and other relevant official bodies that could be involved in the process approval of investigational medicinal product and medical devices. This covers the initial Clinical Trial Applications and any other life-cycle submissions required to maintain the CTA such as amendments, notifications, and clinical study report. Regular contact and communication with the RA/EC throughout the clinical trial is a standard norm.

Clinical Trial Information System (CTIS)

CTIS is the online system for the regulatory submission, authorization and supervision of clinical trials in the EU and the European Economic Area. It is a single-entry point for all clinical trial data. As of 31st January 2023, the use of the CTIS is mandatory for all initial submissions.

SanaClis is fully prepared to support our clients during this transition, allowing them to significantly reduce time and cost, while standardizing their processes within EU Member States and the EEA.

CTIS: Impact, Strategic Considerations, and SanaClis' Experience and Solutions

Clinical trials are critical for evaluating the safety and efficacy of new medical products. The Clinical Trial Regulation (CTR) No 536/2014 by the European Union (EU) aims to harmonize and simplify the clinical...

Read the full article here