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.