COSMOS Scientific

What COSMOS Scientific does

COSMOS Scientific is a privately held Contract Research Organization (CRO) that designs, manages, and executes clinical trials for medical device companies seeking market entry across Latin America, with a primary operational base in Colombia and a US headquarters in Miami, Florida. Founded in 2018 by Dr. Carlos A. Valverde, MD, MSc., the firm positions itself as a regional specialist navigating multi-jurisdictional regulatory frameworks including INVIMA (Colombia), COFEPRIS (Mexico), ANMAT (Argentina), and ISP (Chile), while maintaining alignment with international standards from the FDA, EMA, ICH, and WHO. Its client roster spans medical device startups (MIVI Neuroscience, ForSight Vision, Ivantis, Galaxy Therapeutics, eyeFlow, STROMA Medical, Vytron US, Syntheon, Manual Surgical Sciences), enterprise medical device manufacturers (Johnson & Johnson Vision), pharmaceutical companies (PTC Therapeutics, PROCAPS), other CROs (Labcorp, Genae), pharmacovigilance specialists (Prima Vigilance), healthcare insurance (SURA), regulatory affairs consultancies (PRMA Consulting), clinical research sites (Clínica Oftalmológica del Caribe), and academic institutions (UTP).

The company's product portfolio comprises four core service lines: Clinical Trials for Medical Devices (end-to-end trial design, project management, site and investigator identification, monitoring, subject recruitment, and data management), Medical Affairs Services (medical writing, advisory boards, expert consensus programs, KOL mapping and engagement, clinical practice guidelines, and Real World Evidence generation), Pharmacovigilance Services (adverse event collection and reporting, signal detection, SUSAR management, PSUR/RMP/DSUR preparation, and local QPPV representation), and Training Programs (medical device design, healthcare entrepreneurship, clinical research methods, GCP, and technology transfer). There is no proprietary technology platform underpinning these services; the offering is built on human regulatory and clinical expertise rather than software infrastructure, and no AI/ML capabilities, APIs, or integrations are disclosed.

COSMOS Scientific operates a consultative B2B sales model with quote-based pricing tailored to engagement scope, using content marketing through a blog covering medical device and regulatory topics as its primary top-of-funnel channel and direct phone/email contact for bottom-of-funnel enterprise engagement. The firm is founder-controlled and bootstrapped, with no disclosed institutional investment, funding rounds, or parent company. Headcount sits at 1-10 employees, and revenue is not publicly disclosed.

Name

COSMOS Scientific

Legal name

COSMOS Scientific

Website

https://cosmosscientific.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

COSMOS Scientific is a privately held Contract Research Organization that runs clinical trials for medical device companies and provides Medical Affairs, Pharmacovigilance, and training services to pharmaceutical and device firms across Latin America, anchored in Colombia with US headquarters in Miami.

Ownership category

akta.pro rank

Product category

Contract Research Organization / Clinical Research Services

NAICS

Scientific Research and Development Services (5417), Professional, Scientific, and Technical Services (541)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro industry

PRIMARYHLAGAAAA

Clinical CROs (Phase I–IV)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAAAH

Pharmacovigilance, Risk Management & Medical Affairs CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAAAG

Medical Writing & Regulatory Submission Support CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

Keywords

• Clinical trial services
• Medical device research
• Pharmacovigilance services
• Medical affairs services
• Regulatory affairs consulting

Headquarters

HQ city

Miami

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Trials for Medical Devices: End-to-end clinical trial services including design, management, execution, site monitoring, and data management for medical devices across Colombia and Latin America.
2. Medical Affairs Services: Medical writing, advisory boards, expert consensus programs, clinical practice guidelines development, KOL mapping, and Real World Evidence generation for pharmaceutical and medical device companies.
3. Pharmacovigilance Services: Adverse event collection and reporting, signal detection, regulatory inspection readiness, QPPV support, PSUR/RMP/DSUR preparation, and safety monitoring for clinical trials and post-marketing surveillance.
4. Training Programs: Specialized training courses covering medical device design, healthcare entrepreneurship, clinical research methods, GCP, and technology transfer for professionals and researchers.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels2 records

Core offering

COSMOS Scientific is a Contract Research Organization (CRO) that designs, manages, and executes clinical trials for medical devices across Colombia and Latin America. It complements these trial services with Medical Affairs support (medical writing, advisory boards, KOL mapping, clinical practice guidelines, Real World Evidence), Pharmacovigilance services (ADR reporting, signal detection, PSUR/RMP/DSUR preparation, QPPV support), and specialized Training Programs for healthcare professionals and researchers.

Product overview

COSMOS Scientific operates as a Contract Research Organization (CRO) offering a unified portfolio of clinical research services for medical device and pharmaceutical companies. The four core service offerings—Clinical Trials for Medical Devices, Medical Affairs Services, Pharmacovigilance Services, and Training Programs—work together to support clients from product development through market launch and post-market surveillance. Clinical Trials provides end-to-end trial management with regulatory strategy and site operations; Medical Affairs delivers scientific communication and evidence generation including Real World Evidence; Pharmacovigilance ensures safety monitoring and regulatory compliance; and Training Programs builds client capacity in clinical research competencies.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Trials for Medical Devices End-to-end clinical trial services for medical devices including regulatory approval navigation, site and investigator identification, protocol development, project management, site monitoring, subject recruitment, and data management across Colombia and other Latin American countries.
• Medical Affairs Services Comprehensive Medical Affairs support for pharmaceutical and medical device companies, including medical writing, advisory boards organization, expert consensus programs, KOL mapping and engagement, clinical practice guidelines development, and Real World Evidence generation.
• Pharmacovigilance Services Drug safety monitoring services including adverse event collection and case management, signal detection, regulatory inspection readiness, literature surveillance, preparation of safety reports (PSURs, RMPs, DSURs), clinical trial safety monitoring, and local QPPV representation aligned with ICH, WHO, EMA, and FDA standards across Latin American countries.
• Training Programs Specialized capacity-building courses for professionals, researchers, and innovators covering medical device design and development, healthcare entrepreneurship, clinical research methods, clinical trial management, Good Clinical Practice (GCP), and technology transfer in medical devices.

Named customers19 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators2 records

Recent moves4 records

Expansion highlights4 records

Broad incumbents

• Medpace: Large publicly traded clinical CRO with global operations; competes for the same medical-device and pharma sponsor business as COSMOS but at significantly larger scale.
• IQVIA: Largest global CRO and life sciences services provider; competes across clinical operations and post-marketing services that COSMOS offers, particularly as it expands LatAm presence.
• Parexel: Large global CRO serving pharma and medical device sponsors; directly comparable service portfolio (clinical trials, pharmacovigilance, regulatory) at substantially greater scale.
• ICON plc: Global CRO with extensive device and pharmaceutical trial capabilities; overlapping customer base with COSMOS and direct competition in LatAm device trials.
• Charles River Laboratories: Global CRO with device-focused and early-stage research capabilities; overlaps with COSMOS's clinical and medical device services, especially as it expands into LatAm.

Regional players

• Novotech: Asia-Pacific-focused CRO with regional depth analogous to COSMOS's LatAm focus; comparable as a regionally specialized CRO, though operating in a different geography.

Direct peers

• Clinipace Worldwide: Mid-size global CRO with multi-therapeutic trial management; comparable in scale and B2B CRO model, though broader geographic footprint than COSMOS.
• Cromsource: Mid-size European-headquartered CRO providing clinical research, staffing, and consulting; operates at similar scale to COSMOS with comparable full-service CRO model.
• Worldwide Clinical Trials: Mid-size clinical CRO offering Phase I-IV trial management and post-approval services; directly comparable operating model to COSMOS, though larger and broader in therapeutic and geographic scope.
• CTI Clinical Trial & Consulting Services: Mid-size CRO with strong expertise in niche and rare-disease trials; comparable in size, therapeutic specialization, and B2B CRO positioning to COSMOS.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/cosmos-scientific

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 COSMOS Scientific