Assistance

Safety Observer S.A.S. is a niche company incorporated in France since 2013, which provides Regulatory Intelligence services to the Pharma and Biotech Industry.

Although Safety Observer S.A.S. started operating as an independent company in 2013, the service exists since 2005. It was born from a partnership between PV Focus and SUNNIKAN Consulting, two companies well known in France and Europe in the field of Pharmacovigilance Quality Assurance and Audits.

We all know it is hard and time-consuming to keep up with the flow of regulatory information to maintain compliance in Pharmacovigilance Operations. At Safety Observer, we actively monitor identified sources and bring you the level of information you need to stay on top of applicable regulatory requirements.

Some companies have dedicated people for Regulatory Intelligence. Safety Observer offers the possibility to share the costs with other companies, thus bringing significant savings to your company.

As of 2024, our Regulatory Intelligence Reports are used by more than 100 client organisations, including over 70 Pharma and Biotech companies. The service is also used by a range of Service Providers and Public Hospitals.

The Safety Observer Reports provide information relevant to Pharmacovigilance and Clinical Drug Safety for Human Medicinal Products, including Biological Products and Vaccines. Please note that the reports do not cover Medical Devices, and only Combination Products are covered (i.e. products combining a Medicinal Product and a Device).

The Safety Observer Reports provide a concise summary of relevant updates with direct links to the sources for all announcements regarding regulatory requirements and actions in the field of Pharmacovigilance and Clinical Drug Safety. This includes new and draft regulations and guidelines, as well as Product Alerts and other relevant news.

The Safety Observer Reports contain information from 2 categories of sources:

• “Core” sources: This designates the sources under systematic and active surveillance, including International sources (ICH, CIOMS, etc.), European sources (EMA, EU Commission, CMDh), and selected National Agencies (US FDA, MHRA, ANSM). Admittedly, the selection of the “Core” sources is influenced by language, as the current capabilities include the surveillance of updates published in English or French.
• “Other” sources: This includes all other authorities. Although some are subject to systematic surveillance (e.g. Australian TGA, Health Canada, Swissmedic), some publications are identified through secondary sources (e.g. Service Providers, Law Firms, News Agencies, Social Media, etc.). Although these secondary sources may occasionally involve delays or varied reliability, they contribute valuable additional insights.

The Safety Observer Reports are produced following a standard template with a user-friendly structure built after years of practice and user feedback. From 01-Jan-2025, Safety Observer Reports include the following sections:

• 01 – Highlights: This section provides an overview of the most critical updates presented in the report with links to the corresponding articles.
• 02 – Regulations & Guidelines (Core): This section presents final and draft standards published by core sources.
• 03 – Regulations & Guidelines (Other): This section presents final and draft standards published by other sources.
• 04 – The Safety Observer Tracker: This section provides a reminder of the upcoming implementation dates and consultation deadlines in a tabular format.
• 05 – Product Safety Alerts (Core): This section presents Safety Alerts published by core sources.
• 06 – Safety Letters & Newsletters (Core): This section presents Dear Doctor Letters & Safety Newsletters published by core sources.
• 07 – Other publications by Core Agencies: This section presents other information published by core sources, including information associated to projects & agency meetings, and may include product-related information that was not communicated through a Product Safety Alert.
• 08 – Quality Assurance, Inspections and Audits: This section is mainly intended to present information published by authorities (Core and others) in relation to inspections, including inspection metrics and warning letters.
• 09 – Other News and Resources: This section is intended to present any other relevant news, including litigation activity and scientific articles on topics of interest.
• 10 – Conferences & Training Events: This section presents leading events from a range of organisations including DIA, DSRU and RQA.

The detail of the changes made to the previous report structure is provided in the attached file: ToC Revision 2025

Each article includes information to facilitate the impact assessment by users, with a self-explanatory heading, a few lines describing the scope and content of the release, and hypertext links to the source material. Where possible, we would also highlight the key points of the release and/or the main differences with the previous version.

Our reports do not include an in-depth analysis of the new guidance and requirements but bring you the information that is relevant to evaluate the impact for your company, and access to the source material for further in-depth review. Our main contribution is to make our clients aware of important updates in a timely manner to support continuous compliance in their Pharmacovigilance System.

Feel free to contact us if you have further questions (Contact Form at the bottom of this page). A Free Platform Demo with a sample report is also available (see Top of this page).

In the past, our Regulatory Intelligence Reports were distributed in Adobe PDF format but since the end of 2023, reports are made available through our web-based Reading Platform.

All users with an active subscription can access the Reading Platform from any web browser, where the full library of reports is available (since January 2023). All users are notified by email when a new report is published.

The functionalities of the platform include:

• Search: Users can perform searches within and across reports
• ToC Export: This functionality allows users to export the Table of Contents (ToC) of individual reports to Excel. This is intended to support clients in documenting their internal Impact Assessment. The resulting table contains the headings of the report in the form of hyperlinks to the corresponding article, and the selected dates. Users can add columns to the table with the information they need (e.g. Subject Matter Expert, Result of Impact Assessment, etc.) and share it with registered users of the Platform, who will be directed to the corresponding article with a simple click on the heading.
• Account monitoring: Each User Account can be used from a maximum of 2 authorised devices (e.g. a laptop computer and a smartphone). The platform provides tools to monitor User Accounts in order to prevent unauthorized account sharing and content dissemination.

There are short video tutorials available, which provide a guided tour of the platform and its features. A Free Platform Demo with a sample report is also available (see Top of this page).

Our Regulatory Intelligence Reports are produced on a monthly basis. However, Safety Observer does not publish in August and the September Report includes all relevant information from July and August. There are therefore 11 Reports per year but we may produce additional Special Reports if we consider that there is significant information that requires immediate attention.

Every effort is made to deliver our Regulatory Intelligence Reports on the 10th of the month at the latest.

We offer a secure online payment option accepting major Credit Cards (Visa, MasterCard and American Express). However, clients can also select a payment by bank transfer, which must be received within 30 days of the date of the invoice. In this case, we expect the client to pay for all banking fees associated to the bank transfer.

The process for renewals is the same as for the initial subscription, i.e. clients must place a new order for the Subscription Plan that meets their needs.

The distribution email for each Regulatory Intelligence Report includes a reminder to all clients about the term of their subscription. In addition, we will notify you as soon as your subscription has expired, immediately after the last report on your subscription is distributed, which leaves clients a month to process the renewal and avoid any interruption of the service.