GNP Guia Naghi & Partners The Legal 500 – The Clients Guide to Law Firms
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Pharma & Regulatory

Medicines and medical devices

Authorization process (full-fledged assistance).

Regulatory compliance (good practice manuals, contract reviews etc).

Inspection assistance.

Clinical studies.

HTA approvals and health protocols.

Publicity and educational campaign approvals.

Sponsorship and donations.

Cost-volume and cost-volume-result contracts.

National programs.

Assistance with public acquisitions (centralized or hospital-level).

Distribution models and contracts (full-fledged assessment, negotiations, contract drafting, authority approvals, implementation assistance).

Pricing (review, approval, challenges).

Claw back (computation, challenges).

Obtaining guidelines / interpretations from relevant stakeholders.

Commercial policies.

Assessment of pass-through discount models, pharmacy level loyalty programmes.

Health care services

Contract review and approval.

National Health Insurance House collaboration/ disbursement assistance.

Inspection assistance.

Compliance and regulatory assessment.

Obtaining guidelines / interpretations from relevant stakeholders.

Commercial policies.



Reimbursed medicines list updating – legal arguments and approach.

Vaccines legislation.

Reimbursement streamlining legal proposals.

Alternative financing sources legislation drafting.

Participation to working groups, events and white papers.






Our track-record

International producer of medicinal products and vaccines.

Negotiating and signing the first direct award national procurement contract based on quality and public health objectives. Designing of the market entry processes for newly launched vaccines.


International producers of medicinal products.

Price approvals for innovative medicines. Cost volume contract negotiations. Pricing and discount policy reshaping.


Global biopharma company.

Assistance with the set-up of an alternative wholesale distribution system in Romania.


International dominant producers of medicinal products.

Redesigning of the business model and implementation of Direct to Hospital and Direct to Pharmacy models.