Fees

Type of consultancy	Fees
Scientific advice on new drug development
Pharmaceutical quality requirements
Interpretation of directives and quality guidelines for medicinal products	100 000 Ft + VAT
Pharmaceutical quality issues related to drug development (Quality questions)	280 000 Ft + VAT
Assessment of ancillary medicinal substances incorporated in medical devices (first request)	1 180 000 Ft + VAT
Assessment of ancillary medicinal substances incorporated in medical devices - substantial modification (as new manufacturer of the active substance supported by an ASMF, new indication etc.)	550 000 Ft + VAT
Assessment of ancillary medicinal substances incorporated in medical devices - non-substantial modification (as expiry date, new CEP version for an already approved manufacturer etc.)	270 000 Ft + VAT
Non-clinical or clinical development
Consultancy related to non-clinical or clinical development of medicinal products	170 000 HUF + VAT
We provide 50% discount on the specified service fee for micro-enterprises
We provide 90% discount for: - an institution belonging to the Lóránd Eötvös Research Network, - a higher education institution providing training with a state scholarship, - a state-run, municipally health institution, - public funding primary health care insitutions, - HECRIN, - not-for-profit organisation and academia (institutions and individuals) champions in drug repurposing program (see https://www.ema.europa.eu/en/documents/other/question-answers-repurposing-pilot-project-proposal-framework-support-not -profit-organisations_en.pdf)
We reserve the right to establish a fee waiver.
Clinical trial
Consultancy related to clinical trial of medicinal products	280 000 HUF+VAT
We provide 50% discount on the specified service fee for micro-enterprises
We provide 90% discount for: - an institution belonging to the Lóránd Eötvös Research Network, - for a higher education institution providing training with a state scholarship, - for a state-run, municipally health institution, - for public funding primary health care insitutions, - for HECRIN, - for not-for-profit organisation and academia (institutions and individuals) champions in drug repurposing program (see https://www.ema.europa.eu/en/documents/other/question-answers-repurposing-pilot-project-proposal-framework-support-not -profit-organisations_en.pdf)
We reserve the right to establish a fee waiver.
Scientific advice on pharmacovigilance issues
Consultancy on pharmacovigilance issues related to new drug development	280 000 HUF + VAT
Interpretation of requirements and defining obligations in individual cases	100 000 HUF + VAT
Changing prescription status (OTC switch)	140 000 HUF + VAT
PASS, DUS, RMP, RMM etc.	280 000 HUF + VAT
Quality assurance systems (GLP, GCP, GMP, GDP, GVP)
Authorization and inspection	140 000 HUF + VAT
Quality (assurance) systems (GxP)	140 000 HUF + VAT
Consultancy related to manufacturing authorisations (GMP)	170 000 HUF + VAT
Consultancy related to pharmaceutical wholesale activity (GDP)	140 000 HUF + VAT
Scientific advice related to applications for marketing authorisation
Legal basis of application	100 000 HUF + VAT
Brand name	100 000 HUF + VAT/5 names
Packaging, SPC and package leaflet	100 000 HUF + VAT/SPC or leaflet
Marketing	150 000 HUF + VAT
Consultancy related to advertisements of medicines (including questions related to handing over free medicine samples and donation practice)	150 000 HUF + VAT
Regulatory process, in general	100 000 HUF + VAT
Consultancy on presumed or proven drug quality discrepancies and failures	80 000 HUF + VAT
Consultancy on patient support programs	120 000 HUF + VAT
Advice on the application of legislation	120 000 HUF + VAT
Consultancy on other medicinal products or complex category	Individual price offer
Consultancy on health-technology assessment
Consultancy on clinical and economic analyses of medicinal products	600 000 HUF + VAT
Consultancy on medical devices
Requirements for qualifying for a medical device	100 000 HUF + VAT
Consultancy on trading and distribution (for authorised product)	100 000 HUF + VAT
Consultancy on registration of devices	140 000 HUF + VAT
Consultancy on medical device software/app	140 000 HUF + VAT
Consultancy on "Gyógyászati segédeszköz" distribution and advertising	100 000 HUF + VAT
Consultancy on clinical studies of medical devices	140 000 HUF + VAT
Consultancy on issues dedicated to the OGYÉI Department of District Pharmacists
Consultancy on the appropriateness of pharmacy-specific software	560 000 HUF + VAT
Assessing IT developments and e-health applications	560 000 HUF + VAT
Automated systems for effective drug supply	1 180 000 HUF + VAT
Assessing IT devices and software products related to specific clinical pharmacy activities	1 180 000 HUF + VAT
Face-to-face meeting (max. 90 mins- In addition to the advice fee)	90 000 HUF + VAT
If it is necessary to involve an external expert, we will send a price offer. Please note that in case of early development consulting, if the involvement of an external expert is necessary, we will decide on the payment of the expert's fee based on an individual assessment.

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