Expertise

Public affairs and regulatory affairs: what are we talking about?

Public affairs covers all actions aimed at representing and defending an organisation's interests before public decision-makers: members of parliament, ministries, government agencies and local authorities. In France, these activities are governed by the Sapin II Act, which requires interest representatives to register with the HATVP (Haute Autorite pour la transparence de la vie publique, the French high authority for transparency in public life).

Regulatory affairs, for their part, concern the compliance of a company's products, services and practices with the applicable rules and regulations. These two dimensions are closely linked, and mastering both is essential to anticipate the impact of regulatory change on your business.

Anticipating legislative and regulatory developments

Laws and regulations evolve constantly. A new European directive, a finance act or a decree can radically transform your competitive environment. MOSAIK provides legislative and regulatory monitoring targeted at the topics that affect your business. We analyse the bills under discussion in the French Parliament and the public consultations under way, to give you the time you need to adjust your business model before the new rules take effect.

Regulatory compliance: securing your operations

Obtaining the necessary authorisations

Many sectors require prior authorisation before products or services can be marketed: marketing authorisations for medicines and medical devices, licences for banking and insurance activities, licences for telecommunications operators, type approval for technical equipment. MOSAIK prepares your authorisation files and manages the dialogue with the competent authorities to ensure the smooth handling of your application.

Maintaining ongoing compliance

Compliance does not end once an authorisation is obtained. Your operations must remain compliant with regulatory developments at all times. MOSAIK puts in place monitoring and control procedures tailored to your sector. In the event of an inspection, we assist you in preparing the required documents and responding to the authorities' observations.

Handling regulatory disputes

If a regulator considers that you are not meeting your obligations, it can impose penalties: a warning, an administrative fine, or the suspension or withdrawal of your authorisation. MOSAIK defends you before these authorities to challenge unjustified penalties and, where appropriate, negotiate the terms of a return to compliance.

The sectors most affected

Healthcare and pharmaceutical industries

Healthcare is one of the most heavily regulated sectors. The ANSM (French medicines agency) strictly supervises medicines and medical devices. Changes in public health policy, pricing and reimbursement conditions have a direct impact on the sector's players. MOSAIK advises on all of these issues.

Finance and insurance

Banks and insurance companies operate under the supervision of the ACPR (French prudential authority) and the AMF (French financial markets authority), which impose complex compliance obligations. We advise you on meeting these requirements and represent you in your dealings with the supervisory authorities.

Energy and environment

The energy transition is driving major regulatory change. Every year, new public policies reshape business models. Understanding and anticipating how they are developed makes it possible to identify upcoming constraints and opportunities to seize.

Digital and telecommunications

The digital sector faces growing regulation: the GDPR, the Digital Services Act, the AI Act, platform regulation. These European texts apply directly to companies in the sector. MOSAIK assists you in bringing your operations into compliance with these regulations.

Why choose MOSAIK for your public and regulatory affairs?

Public and regulatory affairs require far more than a simple reading of the texts. They call for a detailed understanding of how regulatory authorities operate, how applications are examined and where room for negotiation exists. MOSAIK combines in-depth legal expertise with a strong command of institutional dynamics.

Our support is built on anticipating the legislative and regulatory changes likely to affect your business. Through targeted monitoring and a precise analysis of your needs, we help you adapt your decisions in advance and turn regulatory constraints into growth levers. As every sector has its own specific features, we offer tailored support that takes into account your economic environment, the size of your organisation and your strategic priorities.

Public and regulatory affairs are a strategic lever for legally securing your operations. This expertise requires both legal proficiency and a detailed understanding of institutional mechanisms. MOSAIK combines these two dimensions to offer you comprehensive support. Contact us to discuss your strategy and receive tailored advice.

Frequently asked questions

What is the difference between public affairs and lobbying?

The term lobbying often carries a negative connotation in France. Public affairs describes the same reality from a more neutral angle: a legitimate, regulated dialogue between private players and public decision-makers, subject since the Sapin II Act to transparency obligations and registration with the HATVP (French high authority for transparency in public life).

What obligations apply to interest representatives?

Since the Sapin II Act (2016), organisations whose main or regular activity consists of influencing public decisions must register with the HATVP and declare their interest representation activities. Failure to comply exposes them to criminal penalties.

When should MOSAIK be brought in on a regulatory matter?

As early as possible. Acting upstream of an authorisation or licence application is always more effective than corrective action. Likewise, anticipating regulatory change allows you to adapt your strategy before the new rules force you to.