Pharma-Service International s.r.o.

What Pharma-Service International s.r.o. does

Pharma-Service International s.r.o. is a privately held Czech pharmaceutical consultancy headquartered in Prague 1 – Old Town, operating since 2015 (with a predecessor entity dating to 2007) under a 2021 ownership structure of Michal Pohl and Miluše Bernadič. The firm provides integrated pharmacovigilance, regulatory affairs, GxP compliance, and medical writing services to micro, small, and medium-sized pharmaceutical companies seeking market access in the Czech Republic and EU member states. Core service offerings include EU-QPPV (Qualified Person Responsible for Pharmacovigilance) representation, pharmacovigilance system establishment (PSMF), adverse event reporting, regulatory strategy, dossier compilation and eCTD publishing (Modules 1–5), Qualified Person services per Directive 2001/83/EC, and medical writing for RMPs, PSURs, and Clinical Overviews. Adjacent offerings include cosmetic product CPNP notification, medical device MDR registry notification, and in-person professional training seminars.

The company operates as a 11-person B2B professional services firm with a sales-led, direct-engagement go-to-market model, generating revenue through project-based consulting fees and unit-priced training seminars (e.g., 9,500 CZK per 2-day pharmacovigilance course). It serves 'dozens of clients' across multiple portfolio products in the EU, with a stated focus on economically reasonable conditions for resource-constrained smaller pharma companies. Its distribution is concentrated in direct consulting and in-person training at the Prague office, supported by a bilingual (Czech/English) website and LinkedIn presence. The firm maintains minor academic partnerships with Charles University's 3rd Faculty of Medicine and VŠCHT Prague, and holds ISoP membership, reinforcing its scientific positioning. No external funding, no public listing, and no AI-driven product capabilities are disclosed; growth and scale metrics beyond the 38+ audits completed by the QA Specialist are not publicly disclosed.

Name

Pharma-Service International s.r.o.

Legal name

Pharma-Service International s.r.o.

Website

https://pharma-service.cz

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Pharma-Service International s.r.o. is a Prague-based B2B consultancy providing pharmacovigilance, regulatory affairs, GxP compliance, and medical writing services to micro, small, and medium-sized pharmaceutical companies seeking market access in the Czech Republic and EU.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory & Pharmacovigilance Consulting

NAICS

Management Consulting Services (54161)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH)

akta.pro secondary industry

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• Pharmacovigilance consulting
• Regulatory affairs services
• GxP compliance
• Medical writing services
• Pharmaceutical training

Headquarters

HQ city

Prague

HQ country

Czechia

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Revenue model

1. Consulting Services: Professional consultancy services including pharmacovigilance, regulatory affairs, GxP compliance, and medical writing. Services provided to pharmaceutical companies throughout product lifecycle.
2. Training and Education: Individualized pharmacovigilance and regulatory training seminars tailored to various target groups. Training conducted in-person at company office.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Pharma-Service International s.r.o. is a Prague-based B2B consultancy that provides specialized pharmaceutical regulatory, safety, and compliance services to drug developers, manufacturers, and marketing authorization holders. The firm delivers pharmacovigilance, regulatory affairs, GxP compliance, medical writing, and professional training/education services to life sciences clients.

Product overview

Pharma-Service International s.r.o. is a consultancy company providing integrated pharmaceutical industry services. The core offering consists of pharmacovigilance services (EU QPPV/Local PV Contact, PSMF establishment, adverse event reporting, literature monitoring, training), regulatory affairs services (dossier audit, eCTD publishing, regulatory strategy, submission management), GxP compliance services (audits, QMS establishment, Qualified Person services), and medical writing services (RMPs, PSURs, Clinical/Pre-clinical Overview). Additional services include education/training programs and cosmetic/medical device notification support. The services are designed to guide pharmaceutical companies through development stages and assessment periods to successful product launch on the Czech Republic and EU markets.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmacovigilance Services
• Regulatory Affairs Services
• GxP Compliance Services
• Medical Writing Services
• Pharmaceutical Education and Training

Segments5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Three partnerships are on record, tiered minor.

• 3rd Faculty of Medicine, Charles University (3LF UK)minorStrategic or Co-development PartnerAcademic partnership for professional cooperation. Company founder collaborates with the faculty on research and education initiatives. Part of company's commitment to professional growth at national and international level.
• University of Chemistry and Technology, Prague (VŠCHT)minorStrategic or Co-development PartnerAcademic partnership with leading Czech technical university. Company collaborates with faculty for professional development and knowledge sharing in pharmaceutical sciences.
• KapaJi (kapaji.eu)minorStrategic or Co-development PartnerStrategic partner providing support for company's unique client needs and wishes. Nature of partnership appears to be collaborative support services.

Scale indicators3 records

Recent moves10 records

Expansion highlights5 records

Broad incumbents

• Parexel: Major global CRO with dedicated regulatory and pharmacovigilance services. Competes in the broader pharma consulting space with significantly greater resources and integrated offerings.
• ICON plc: Large global CRO offering comprehensive regulatory and pharmacovigilance services alongside clinical research. Represents an incumbent competitor that can offer integrated solutions but typically serves larger pharma clients.
• IQVIA: Global CRO and life sciences services giant offering regulatory affairs, pharmacovigilance, and clinical services. Competes in the broader market with significantly greater scale, geographic reach, and full-service portfolio, often targeting the same SME pharma segment.
• SGS Health Science: Global life sciences services provider offering regulatory affairs, pharmacovigilance, and quality compliance services. Comparable GxP/regulatory portfolio but at much larger scale and broader geographic footprint.

Direct peers

• Diamond Pharma Services: Specialized pharma regulatory and pharmacovigilance consultancy providing EU-QPPV, regulatory affairs, and medical writing services. Comparable SME-pharma focus and service portfolio, particularly relevant given shared EU regulatory expertise.
• NDA Group: Pharmaceutical regulatory affairs consultancy providing drug development, regulatory strategy, and medical writing services. Similar SME pharma target segment and European regulatory expertise make it a close comparable.
• ProPharma Group: Specialized pharma regulatory compliance, PV, and quality consulting firm. Comparable service offering across regulatory affairs, pharmacovigilance, and GxP compliance, with broader geographic reach across multiple regulatory jurisdictions.
• PharmaLex: Mid-sized specialized regulatory affairs and pharmacovigilance consultancy serving pharma clients across EU and globally. Directly comparable service portfolio (RA, PV, QPPV, medical writing) with similar SME pharma focus, though at much larger scale.

Emerging players

• RegLink Solutions: European regulatory affairs and pharmacovigilance consultancy. Comparable focus on pharma regulatory services with EU expertise, though smaller scale and more focused geographic presence.
• Pharma Plus Consultancy: Boutique pharma regulatory consultancy offering similar PV, RA, and QPPV services primarily in European markets. Comparable scale and target client segment for SME pharma companies.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/pharma-service-international-sro

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pharma-Service International s.r.o.