ARROWS helped the client pass the SÚKL inspection

ARROWS Law Firm provided legal advice to a healthcare facility in connection with an inspection by the State Institute for Drug Control (SÚKL). The aim was to ensure full procedural readiness, protect the client's rights, and minimize the risk of sanctions in an environment of tightening regulation. Thanks to timely preparation and active measures, the inspection was handled professionally and without any serious impact on the client's operations.

ARROWS provided comprehensive legal support to the client already during the preparation phase for the SÚKL inspection. The consulting services included a detailed review of internal documentation, in particular standard operating procedures (SOPs), records relating to the storage of medicinal products, expiry date checks, the handling of addictive substances, and documentation on the maintenance of medical devices. The firm also conducted a legal audit of the company's compliance with the Medicines Act, inspection rules, and implementing regulations, and proposed specific measures to eliminate the identified risks even before the inspection itself began.

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During the inspection, ARROWS provided the client with ongoing legal assistance, supervised compliance with procedural rules by the inspection authority, and assisted with responses to specific questions and findings of the inspectors. After the audit was completed, the firm analyzed the audit report and prepared qualified objections to selected conclusions, thereby significantly contributing to reducing the risk of sanctions and successfully closing the entire matter. The result was that the audit was completed without any significant financial penalties, the client's operational continuity was maintained, and a functioning framework for future audits was established.