Legal Preparation and Support for Life Sciences Regulatory Audits

BRACE Law Firm provides sophisticated strategic counsel on navigating regulatory inspections and audits targeting pharmaceutical organizations and medical device companies.

Any regulatory inspection demands rigorous advance preparation by the targeted enterprise. To mitigate corporate risk and prevent overreach by enforcement authorities, it is critical to master the procedural nuances of administrative audits and understand the precise statutory limits of investigating bodies.

Interfacing with Enforcement Authorities During Inspections: Legal Support

The operational activities of pharmaceutical companies and medical device distributors are monitored by multiple state authorities. Specifically, audits and investigations may be initiated by the Federal Antimonopoly Service (FAS), the Federal Service for Surveillance in Healthcare (Roszdravnadzor), the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor), the Prosecutor General’s Office, and various law enforcement agencies.

Legal Representation in Licensing Control and State Oversight

Licensing control over the commercial distribution of medicines and medical devices occupies a critical role in industry oversight. As a general rule, the scope of an unannounced on-site licensing inspection may encompass evaluating the condition of premises, buildings, facilities, technical systems, equipment, and other physical assets utilized by a license applicant or licensee, alongside verifying that personnel qualifications satisfy mandatory statutory criteria.

Federal state oversight within the life sciences sector primarily focuses on evaluating compliance with Federal Law No. 61-FZ, dated April 12, 2010, "On the Circulation of Medicines." These statutory audits closely scrutinize compliance regarding preclinical trials, clinical drug trials, storage, transportation, importation into the Russian Federation, dispensing protocols, commercial sale, clinical use, and the safe disposal of medicinal products, as well as verifying that pharmaceuticals in commercial circulation meet mandatory quality standards.

Defense Strategies in Regulatory Audits: Managing Statutory Requests and Documentation

Entities under investigation are legally obligated to provide the antimonopoly authority (and its officials) upon a reasoned request, within the prescribed timeframe, with all necessary documentation, explanations, and information in both written and oral forms. This mandate covers data constituting commercial, official, or other legally protected secrets, including corporate acts, commercial contracts, certificates, business correspondence, and digital or electronic records. Notably, antitrust investigations by the FAS Russia targeting pharmaceutical corporations for alleged cartel agreements and collusive bidding remain highly prevalent.

The Prosecutor General's Office of the Russian Federation possesses sweeping supervisory powers to enforce compliance with federal legislation, including specialized pharmaceutical and medical law frameworks.

Legal Representation in Regulatory Inspections and Appeals

1. Advising on compliance strategies for all categories of regulatory inspections and corporate audits.
2. Conducting legal assessments to verify the statutory grounds for initiating an enforcement investigation.
3. Reviewing documents and information requests to determine the lawfulness and scope of supervisory demands.
4. Identifying potential liability risks arising from audit findings and developing mitigation strategies to eliminate or reduce administrative penalties.
5. Representing client interests directly before investigating authorities and supervisory bodies during on-site visits.
6. Navigating administrative appeals to challenge unlawful decisions, actions, or omissions of regulatory authorities before superior agencies.
7. Litigating in commercial courts to overturn unlawful regulatory actions and contest wrongful administrative liability resulting from inspections.

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