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 2021, 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 Pharmacovigilance and Clinical Safety Reports include all information relevant to Human Medicinal Products, including Biological Products and Vaccines. Please note that our reports do not cover Medical Devices at this time, and only Combination Products are covered (i.e. products combining a Medicinal Product and a Device).

Our Regulatory Intelligence Reports provide a concise summary and direct links to 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.

Our Regulatory Intelligence Reports result from the systematic monitoring of identified sources of information including EMA, FDA, MHRA, ANSM, ICH, CIOMS, etc.

Admittedly, the selection of the sources we monitor is influenced by language, and the review is limited to information published in either French or English. Consequently, our reports present information with an international impact (e.g. ICH, CIOMS), an impact on the whole of Europe (e.g. EMA, CMDh, European Commission), or national impact for the USA, the UK or France. More recently, we have included the Australian TGA and Health Canada to the list of sources we actively monitor.

Unfortunately, our limited resources and language skills do not allow us to monitor other sources / countries. Such information will however be presented in our reports in case we become aware of relevant announcements through the monitoring of our secondary sources (e.g. News Agencies, Service Providers and Social Media).

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.

Our Reports are produced following a standard template with a user-friendly structure built after years of practice and user feedback. The information is presented to facilitate the impact assessment by our users, with a self-explanatory title for each article, 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 on your processes 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 to request a free sample though the contact form at the bottom of this page !

Our Regulatory Intelligence Reports are distributed in Adobe PDF format. The file includes a watermark indicating the name of the company/subscriber and the number of authorised users included in the subscription, which is intended to discourage unauthorised dissemination. In addition, we may track access to our Reports to verify that our clients comply with the terms of the contract and pay the correct price for the number of users in their organisation, as defined in our pricing policy.

Our Regulatory Intelligence Reports are sent to the e-mail address specified by the client. For multi-user subscriptions, the clients have the possibility to specify an additional back-up e-mail address, which purpose is to ensure that our Reports reach the authorised users in a timely manner even when the main recipient is unavailable.

Internal distribution to authorised users is the responsibility of the client. We recommend that clients set up a group mail box or a rule in the mail client to ensure automatic redirection to authorised users. Some of our clients with global subscriptions have several hundred users and Safety Observer does not have a system to manage such large distribution lists and keep them up-to-date.

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 in terms of duration and number of authorised users.

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.