Legal service
Regulatory and compliance
Counsel for regulated sectors
We provide legal assistance in regulated sectors, where compliance with the regulatory framework and the relationship with regulators are decisive for operational continuity.
Pharmaceutical industry
Relations with ANMDMR (National Agency for Medicines)
Assistance on marketing authorizations, variations, authorization transfers and renewal procedures. Managing correspondence and interactions with the agency.
Pricing and reimbursement
Counsel on drug pricing procedures, inclusion on the list of reimbursed medicines, and relations with CNAS and the Ministry of Health.
Advertising
Review of promotional materials and commercial communications for compliance with the strict rules on medicinal product advertising. Challenging sanctions for misleading advertising.
Pharmacovigilance and reporting
Counsel on obligations to report adverse reactions, the obligations of the qualified person (QPPV), and management of safety incidents.
Claw-back
Assistance in challenging regularization decisions concerning the claw-back tax imposed on drug manufacturers and distributors.
Medical devices
Counsel on compliance with the EU Medical Devices Regulation (MDR), CE marking, and registration and reporting obligations.
Energy, natural resources and environment
ANRE regulation
Counsel on licenses for the production, transport, distribution and supply of electricity and natural gas. Assistance in relations with ANRE and the competent authorities.
Oil & gas
Assistance on concession contracts for exploration and production, sector regulations, natural gas transit, and relations with ANRM. We have advised a major oil & gas player in regulatory and administrative litigation.
Environmental regulation
Assistance in dealings with environmental authorities (Environmental Guard, APM, ANPM), challenging sanctions, obtaining and maintaining integrated environmental permits.
Environmental Fund
Assistance in challenging additional recycling obligations set by the Environmental Fund Administration. We have direct experience managing AFM audits.
Renewable energy
Counsel on the regulatory framework for renewable energy projects (PV, wind), permits, licenses, and contracts.
Telecommunications and media
ANCOM regulation
Assistance in obtaining authorizations, compliance with reporting obligations, and relations with the telecommunications regulator.
Use of public property
Counsel on the fees imposed on telecom operators for the use of public property owned by local authorities.
Setting up shared service centers
Counsel on the applicable regulatory framework, including representation before ANCOM.
Do you have a situation you would like to discuss?
Contact us for a preliminary assessment. We analyze the case together and outline the options available to you.
Schedule a consultation