Quinta-Analytica

What Quinta-Analytica does

Quinta-Analytica s.r.o. is a Czech-based, GxP-certified contract research organization founded in 1997 that provides integrated analytical development, bioanalytical, GMP quality control, and clinical bioequivalence/bioavailability services to pharmaceutical and biotechnology companies. Its service portfolio spans the development lifecycle: analytical R&D (method development and validation, impurities, degradation, trace, and nitrosamine analyses), pharmaceutical analyses under GMP (validation, stability including HAPIs, GMP batch release), biologics characterization and cell-based assays for biosimilars and ADCs, and in-house BE/BA/PK clinical studies. Differentiated technical assets include proprietary UPLC/MS/MS nitrosamine detection validated for 24 nitrosamines using isotopically labeled internal standards, an on-line HPLC-SEC-ICP/MS method for ferric carboxymaltose bioequivalence, ADC intact mass spectrometry workflows, and a newly installed Agilent 7850 ICP-MS for elemental and speciation analysis.

The company operates from three Czech sites: a headquarters and central laboratories/clinic in Prague, a dedicated R&D laboratory in Brno (built with EU Regional Development Fund support), and an Ostrava clinical unit that opened in December 2023 with 36-bed capacity, bringing combined clinical capacity to 96 beds. Regulatory standing includes GMP, GLP, and GCP certifications for human medicinal products and GMP for veterinary medicinal products, regularly audited by the Czech State Institute for Drug Control (SÚKL); more than 12 successful FDA inspections historically, with two additional clean inspections in 2025; and GCC bioequivalence center recognition completed in April 2026. Operations are organized as a subsidiary of Conscio Group, with an affiliated US entity, Conscio Pharmaceuticals Inc., established to support North American client engagement alongside the Kiel Laboratories channel partnership for 505(b)(2) NDA pathways.

Quinta-Analytica generates revenue through fee-for-service engagements sold primarily through direct enterprise field sales, supplemented by industry conference presence (CPHI Worldwide) and joint educational webinars. Customer segments include generic pharmaceutical companies requiring BE/BA studies, innovators pursuing 505(b)(2) NDA pathways, biotech firms working on biologics, biosimilars, and ADCs, and veterinary medicine companies requiring GMP QC. Named customers span Kiel Laboratories (US strategic partner), Novavax (6,000 samples tested in 2022 for COVID-19 vaccine scale-up), Adamed Pharma (10-year partnership), SOTIO, Herantis Pharma, Greene Street Pharmaceuticals, Swipp, and İDE CSO. Pricing is quote-based and not publicly disclosed. The company is privately held under Conscio Group with BBA CapitalPartners having invested in 2022; revenue figures are not publicly reported.

Name

Quinta-Analytica

Legal name

QUINTA-ANALYTICA s.r.o.

Website

https://quinta.cz

Company type

Private

Founded year

1997

Operating status

Operating

Headcount range

11–50 employees

Short description

Quinta-Analytica is a Czech-based, GxP-certified contract research organization offering analytical R&D, bioanalysis, GMP quality control, and clinical BE/BA/PK services to generic and innovative pharmaceutical, biotech, and veterinary medicine companies across the EU, US, and Middle East.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715), Medical Laboratories (621511)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734), Services-Medical Laboratories (8071)

akta.pro primary industry

Small-Molecule Analytical Development & Method Validation (CMC) (HLAGAHAF)

akta.pro secondary industries

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Release Testing & Batch Certification (QC) (HLAGADAC), Data Management, Biostatistics & Statistical Programming FSP (HLAGAOAB), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• Pharmaceutical contract research
• Bioanalytical testing services
• Clinical bioequivalence studies
• Analytical method development
• GMP quality control

Headquarters

HQ city

Praha

HQ country

Czechia

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Clinical Testing Services: In-house BE/BA/PK studies conducted in two clinical units with over 300 studies completed. Includes clinical operations, pharmacovigilance, and study monitoring.
2. Bioanalytical Testing: GLP/GCP bioanalysis for preclinical and clinical studies up through Phase III, including method development, validation, and statistical evaluation using LC-MS/MS and other analytical techniques.
3. GMP Quality Control: Pharmaceutical analyses including validation of analytical methods, quality control, stability studies (incl. HAPIs), and GMP batch release.
4. Analytical R&D: Method development and validation, impurities research, degradation studies, trace analyses, and nitrosamine analysis for pharmaceutical development.
5. Biologics Quality Control: Characterization and GxP validation of bioanalytical methods, method transfer, and cell-based assays for biologics and biosimilars.
6. API Solutions: Sourcing and supplying active pharmaceutical ingredients from verified manufacturers, including identification, audit, and quality verification services.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Quinta-Analytica is a GxP-certified Contract Research Organization offering end-to-end pharmaceutical development services across analytical R&D, GMP quality control, GLP/GCP bioanalytical testing, and in-house clinical BE/BA/PK studies. The company supports pharmaceutical, biotechnology, and generic-drug developers from method development through regulatory submission, operating from laboratories and clinical units in Prague, Brno, and Ostrava, Czech Republic.

Product overview

Quinta-Analytica is a full-service GxP-certified Contract Research Organization (CRO) offering an integrated portfolio of pharmaceutical development services organized around three core pillars: Analytical Services (Analytical R&D, Pharmaceutical Analyses, Biologics Analysis, Cell-based Assays, Bioanalytical Testing, and Nitrosamines Analysis), Clinical Services (Clinical Testing with in-house BE/BA/PK studies, Study Monitoring, and Pharmacovigilance), and Regulatory/CMC Support (API Solution, Module 3 Audit, and IMPD Compilation). The company operates multiple laboratory and clinical sites in Prague, Brno, and Ostrava, Czech Republic, providing end-to-end capabilities from early development through regulatory submission. Services are performed under GLP, GCP, and GMP quality systems with certifications for both human and veterinary medicinal products.

Differentiator

Problem solved

Functional benefit

Products and services

• Analytical R&D Method development and validation, impurities research, degradation studies, trace analyses, and nitrosamine analysis for pharmaceutical compounds. Service is delivered to pharmaceutical and biotech sponsors requiring analytical R&D support.
• Pharmaceutical Analyses Validation of analytical methods, GMP quality control, stability studies (including HAPIs), and GMP batch release testing for small molecule pharmaceuticals at GMP-certified sites in Prague and Brno.
• Biologics Analysis Characterization and GxP validation of bioanalytical methods, method transfer, and cell-based assays for biologics, biosimilars, and antibody-drug conjugates. Services support regulatory submissions for complex biologics.
• Cell-based Assay Cell-based testing services supporting biologics and biosimilars development, characterization, and GxP-compliant validation of bioanalytical methods.
• Bioanalytical Testing GLP/GCP bioanalysis for preclinical and clinical studies up through Phase III, including statistical evaluation of pharmacokinetic data, using LC-MS/MS and complementary analytical techniques.
• Clinical Testing In-house BE/BA/PK studies conducted in two GCP-certified clinical units (Prague and Ostrava) with 96 combined beds and over 300 completed studies, covering bioequivalence, bioavailability, and pharmacokinetic studies under GCP.
• Nitrosamines Analysis Detection and quantification of nitrosamine impurities using isotopically labeled standards and customizable in-house UPLC/MS/MS methods, validated for APIs, solid dosage forms, solutions for infusion, oral solutions, and semi-finished products.
• API Solution Sourcing and supply of active pharmaceutical ingredients from verified manufacturers, including niche APIs, with quality auditing and GMP-compliant delivery to pharmaceutical sponsors.
• Clinical Study Monitoring Oversight of participant health and correctness of treatments during clinical studies, provided as part of clinical study operations.
• Pharmacovigilance Monitoring of daily routine to detect unrecognized adverse events and assess drug safety during clinical development.
• Module 3 Audit Thorough dossier Module 3 data audit to ensure consistency and compliance with regulatory requirements for marketing-authorization submissions.
• IMPD Compilation Compilation of the Investigational Medicinal Product Dossier (IMPD) for EU-based clinical trial applications.
• GMP Quality Control GMP-certified quality control testing for human and veterinary medicinal products at Prague and Brno sites under continuous SÚKL and US FDA audit framework.
• Formulation Development Formulation development services including novel drug delivery systems, transdermal patches, orally dissolving films, and topical products for pharmaceutical sponsors.

Quantifiable outcome

• Over 300 BA/BE/PK studies completed
• +5 more outcomes

Named customers8 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature8 records

Partnerships

Eight partnerships are on record, tiered minor and core.

• SigutLabsminorStrategic or Co-development Partner · 25 March 2026Joint webinar on ADC Performance by Design covering linker chemistry, DAR control, and analytical strategies. SigutLabs contributes chemistry expertise while Quinta provides bioanalytical insight.
• Herantis PharmaminorStrategic or Co-development Partner · 9 July 2025Testimonial collaboration for HER-096, a peptidomimetic candidate for Parkinson's disease treatment. Quinta provides analytical development and nonclinical support as the drug advances to Phase 1b trials.
• SwippminorStrategic or Co-development Partner · 9 June 2025Development partnership for world's first midazolam buccal film. Quinta provided GMP audit, bioavailability assessment, clinical study execution (3 trials with 60 volunteers), and bioanalytical analysis. Product now in outlicensing negotiations with European pharma company.
• Adamed PharmacoreStrategic or Co-development Partner · 2 December 202410-year partnership spanning pharmaceutical innovation projects. Collaboration covers analytical development and development support for pharmaceutical products.
• NovavaxcoreStrategic or Co-development Partner · 1 January 2020Collaboration began in 2020 during pandemic for COVID-19 vaccine production support. Quinta provided quality control testing including raw material testing (water content, elemental impurities, identity, assays, microbiological assays), GMP analyses. In 2022 alone, tested almost 6000 samples.
• Kiel LaboratoriescoreStrategic or Co-development PartnerUS-based pharmaceutical R&D company specializing in 505(b)(2) NDA development. Long-standing partnership (nearly a decade) for API sourcing, analytical services, and method development. Kiel serves as strategic partner and trusted representative for US market, particularly for FDA approval pathways.
• İDE CSOminorStrategic or Co-development PartnerClinical partnership for Ferric Carboxymaltose bioequivalence study. İDE CSO (based in Ankara, Turkey) responsible for clinical part of the study while Quinta handled bioanalytical services.
• Conscio GroupcoreOthersParent company network. Quinta-Analytica is part of Conscio Group, a network of quality science organizations including Gen-Plus (Germany), LVA (Austria), EL Labs (Slovakia), HyServe (Germany), Ekolab (Slovakia), and Reference Analytics.

Scale indicators10 records

Recent moves8 records

Expansion highlights7 records

Broad incumbents

• WuXi AppTec: Global CRO/CDMO offering bioanalytical, biologics characterization and clinical services to pharma and biotech. Comparable to Quinta as a full-service development partner, but with materially larger scale and a broader geographic footprint.
• Charles River Laboratories: Large CRO spanning bioanalytical, biologics and clinical lab services. Competes with Quinta for outsourced analytical and bioanalytical work, particularly in regulated GxP environments.
• Eurofins Scientific: Global testing-services group with deep pharmaceutical and biopharma product-testing capabilities. Directly comparable to Quinta on analytical R&D, GMP QC, nitrosamine and release-testing services.
• ICON plc: Top-tier global CRO providing clinical development and bioanalytical services. Overlaps with Quinta on clinical operations and bioanalytical testing for pharma sponsors.
• IQVIA: Largest global CRO with integrated clinical, bioanalytical and laboratory services. Competes for the same pharma and biotech sponsor budget that Quinta targets, particularly on clinical and bioequivalence work.
• SGS Life Sciences: Global testing network with pharmaceutical lab services including bioanalytical, GMP QC and stability testing. Competes with Quinta for outsourced pharmaceutical analytical and QC work.

Direct peers

• Medpace: Mid-sized full-service CRO focused on small- and mid-sized pharma/biotech sponsors across clinical, bioanalytical and regulatory services. Closely comparable to Quinta on customer profile and integrated service model.
• Celerion: Specialized early-stage clinical and bioanalytical CRO focused on BE/BA/PK and first-in-human studies. Closely comparable to Quinta's clinical + bioanalytical offering for generic and 505(b)(2) sponsors.

Emerging players

• Frontage Laboratories: US-China bioanalytical and CMC-focused CRO offering LC-MS/MS bioanalysis, biologics and clinical services. Directly comparable on bioanalytical and small-molecule CMC work.
• Pharmaron: Integrated CRO/CDMO with bioanalytical, biologics and CMC services. Comparable to Quinta on integrated drug development offerings across small molecules and biologics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/klinikaquinta
• LinkedInlinkedin.com/company/quinta-analytica

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

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 Quinta-Analytica