Maxima Health Research

Name

Maxima Health Research

Legal name

Maxima Health Research

Website

https://maxima.com.ua

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Regulatory Affairs Consulting

NAICS

Marketing Research and Public Opinion Polling (54191)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

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

akta.pro secondary industries

Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO), Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

Keywords

• Regulatory affairs consulting
• Pharmaceutical product registration
• Pharmacovigilance services
• GMP compliance consulting
• Medical device registration

Headquarters

HQ city

Vyshneve

HQ country

Ukraine

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Regulatory Consulting Services: Professional consulting services for regulatory affairs including product registration, re-registration, pharmacovigilance, GMP confirmation, and post-registration support for pharmaceutical, medical device, dietary supplement, and cosmetic companies.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Maxima Health Research provides B2B regulatory affairs consulting services to pharmaceutical, medical device, biotechnology, dietary supplement, and cosmetic companies. Its offerings cover the full product lifecycle: initial registration and re-registration of medicinal products, medical devices, cosmetics, and food supplements; pharmacovigilance; GMP confirmation; post-registration surveillance and variations; and packaging development. Services are delivered by an in-house team of regulatory experts across Ukraine, EAEU, and CIS jurisdictions.

Product overview

Maxima Health Research is a single-service consulting firm rather than a software product company. Its offering consists of a unified portfolio of regulatory consulting services delivered by a team of in-house experts. The core services include: (1) Registration and Re-registration of Medicinal Products for Ukraine, EAEU, and CIS markets; (2) Registration of Medical Devices with Authorized Representative services for non-resident manufacturers; (3) Registration of Cosmetic Products; (4) Registration of Food Supplements (dietary supplements); (5) Post-Registration Product Surveillance (variation management); (6) Pharmacovigilance services including adverse event monitoring, signal management, PSMF, and RMP; (7) GMP Confirmation; and (8) Packaging Development and Implementation. These services are not modular software products but rather consultancy engagements provided by a team of 20+ regulatory experts, primarily serving pharmaceutical, medical device, and FMCG companies operating in Ukraine and the CIS region.

Differentiator

Problem solved

Functional benefit

Products and services

• Registration and Re-registration of Medicinal Products Regulatory consulting services for the registration and re-registration of medicinal products in Ukraine, EAEU countries, and CIS markets, including dossier preparation, regulatory authority submissions, specialized expertise supervision, laboratory analysis, and marketing authorization issuance. Aimed at pharmaceutical manufacturers seeking or maintaining market authorization for medicines.
• Registration of Medical Devices Conformity assessment and registration services for medical devices in Ukraine and CIS countries, including technical documentation analysis, competent authority submissions, conformity assessment follow-up, packing material development, and Authorized Representative services for non-resident manufacturers. Aimed at medical device manufacturers seeking market access in the region.
• Registration of Cosmetic Products Registration services for cosmetic products in Ukraine, including obtaining the Sanitary and Epidemiological Inspection Report (SEIR) from the State Service of Ukraine on Food Safety and Consumer Protection and compliance certificate issuance. Aimed at cosmetics manufacturers and FMCG companies entering the Ukrainian market.
• Registration of Food Supplements Registration services for dietary supplements (food supplements) in Ukraine, including laboratory testing at accredited organizations, technical documentation analysis, draft labeling preparation, and circulation introduction support. Aimed at FMCG and dietary supplement manufacturers introducing products to the Ukrainian market.
• Post-Registration Product Surveillance Post-approval support services including timely updating and management of registration materials, variation procedures, and maintenance of registration documents for medical devices, dietary supplements, and cosmetic products. Aimed at manufacturers needing ongoing lifecycle management of their registered products.
• Pharmacovigilance Comprehensive pharmacovigilance system services including adverse reaction monitoring, signal detection and management, SOP development, risk management plan (RMP) development, periodic safety update reports (PBRER/PSUR), pharmacovigilance system master file (PSMF) development, and regulatory authority communication. Aimed at pharmaceutical manufacturers needing compliant post-marketing safety oversight.
• GMP Confirmation Services for confirming compliance of medicines manufacturing conditions with Good Manufacturing Practice (GMP) requirements, including document expertise, production site inspection coordination, and obtaining GMP certificates or recognition conclusions from Ukrainian regulatory authorities. Aimed at pharmaceutical manufacturers seeking GMP verification for their production sites.
• Packaging Development and Implementation Packaging design and labeling services including marking text development, graphic layout design, regulatory analysis of packaging, approval for printing, and introduction of package designs into the unified database of the State Service of Ukraine for Medicinal Products. Aimed at manufacturers requiring compliant packaging for the Ukrainian market.

Quantifiable outcome

• Registration timeline: 10-15 months for medicinal products, 4-6 months for medical devices, 1 month for dietary supplements, 1 month for cosmetics
• +1 more outcomes

Named customers12 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• AmgenminorOthersPharmaceutical company served as client for regulatory consulting services including product registration support

Scale indicators4 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Pharmalex: Pharmalex is a regulatory affairs and pharmacovigilance consulting firm serving pharma, biotech, and medical device clients across Europe, CIS, and emerging markets. Direct comparable: also offers registration, PV (PSMF/QPPV), GMP, and quality compliance services as outsourced, non-clinical consulting engagements.
• Arriello: Arriello is a regulatory affairs and pharmacovigilance consultancy with particular strength in Central and Eastern Europe. Direct comparable: serves pharma manufacturers with registration, PV, and quality services across CEE/CIS — closely overlapping with Maxima's geographic and service profile.
• ProPharma Group: ProPharma Group provides regulatory affairs, pharmacovigilance, and quality/compliance consulting to pharma and medical device manufacturers globally. Direct comparable: delivers outsourced PV, GxP quality, and registration services as a people-led consultancy model similar to Maxima.
• ProductLife Group: ProductLife Group is a global regulatory and compliance consulting firm for pharma, medical devices, and consumer health, with strong coverage across Europe and emerging markets. Direct comparable: provides regulatory strategy, registration, PV, and quality/outsourced services analogous to Maxima's full-service portfolio.

Broad incumbents

• Parexel International: Parexel is a top-3 global CRO with broad regulatory affairs and pharmacovigilance capabilities. Broad incumbent: offers overlapping registration, PV, and GMP services as part of a much wider clinical and consulting portfolio, and competes for the same multinational pharma clients as Maxima.
• ICON plc: ICON plc is a leading global CRO offering regulatory consulting and pharmacovigilance alongside clinical operations. Broad incumbent: directly competes with Maxima on multinational pharma regulatory engagements and consolidates regional vendors under single-vendor contracts.
• IQVIA: IQVIA is the world's largest CRO with end-to-end regulatory, clinical, and pharmacovigilance services. Broad incumbent: competes for global pharma regulatory budgets via its dedicated regulatory affairs and safety practice, with growing EAEU/CIS presence.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-to-large global CRO with regulatory, pharmacovigilance, and clinical capabilities. Broad incumbent: offers multi-jurisdiction regulatory services and competes for the same enterprise pharma clients as Maxima on EAEU submissions.

Regional players

• Synapse Research: Synapse Research is a Russia-based CRO and regulatory consultancy serving pharma and biotech in CIS and Eastern Europe. Regional peer: comparable focus on EAEU/CIS regulatory submissions and clinical operations, though headquartered in Russia rather than Ukraine.
• OCT Clinical: OCT Clinical is a CRO headquartered in Russia with operations across CIS and Eastern Europe, providing clinical research and regulatory services. Regional peer: comparable geographic footprint in CIS regulatory and clinical work, and overlaps with Maxima on pharma/biotech client base.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/maximahealth
• LinkedInlinkedin.com/company/maxima-health-research

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 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 Maxima Health Research