Distribution for the health and beauty market in America
Alliance to maximize the coverage and efficiency of your supply chain in America
About the Company
What is Vertex CRO?
Vertex CRO is a company specializing in clinical data analysis, healthcare regulation, regulatory compliance, import and export management of medical supplies, and the regulatory lifecycle of healthcare products. We help companies in the medical, pharmaceutical, and device sectors make informed decisions and comply with national and international regulatory requirements.
What types of companies do you work with?
We work with distributors, manufacturers, pharmaceutical companies, hospitals, clinics, laboratories, medical technology companies, and healthcare startups that require support in research, analysis, validation, or regulatory compliance.
Services and Capabilities
What services does Vertex CRO offer?
We offer comprehensive services in four main areas:
Regulatory compliance (COFEPRIS, FDA, EMA, NMPA, among others).
Clinical and statistical data analysis.
Import and export of medical devices and health products.
Regulatory lifecycle management, from initial registration to modifications, extensions, and post-market surveillance.
Can you assist with COFEPRIS procedures?
Yes. Our team has extensive experience in sanitary registrations, modifications, extensions, import procedures, as well as audits and compliance with applicable regulations in Mexico.
Can you help me export or import medical devices?
Yes. We provide comprehensive consulting services for risk analysis, technical documentation, regulatory compliance, logistics, and sanitary release for import and export.
Do you perform statistical analysis?
Yes, we have experience in:
Identifying business opportunities through market research, price elasticity analysis, competitive analysis, and more.
In the clinical sector, we work with: biometrics, biostatistics, multicenter analysis, and statistical modeling for clinical trials and research projects.
What is the process for starting a project?
Initial assessment.
Review of technical and regulatory documentation.
Work proposal with clear scope, timelines, and deliverables.
Project execution by internal specialists and validated collaborators.
Delivery of results and post-project support.
Frequently asked questions
At VERTEX CRO, we don't just build careers; we build a legacy of health with a human touch.
What documents do I need to begin a regulatory process?
This varies depending on the product classification; however, the following are commonly required:
Technical data sheets and manuals
Certificates of free sale
Manufacturer information
Evidence of safety and performance
Labeling or label draft
Our team will tell you exactly what you need based on your product.
Can you help if I have incomplete documentation?
Yes. We can advise you on reconstructing or updating technical files, preparing dossiers, or locating missing information.
Confidentiality and Quality
How do you handle the confidentiality of my information?
All projects are executed under Non-Disclosure Agreements (NDAs) and internal protocols that guarantee the security and privacy of our clients' data.
Do you comply with international standards?
Yes. Our processes are aligned with international standards such as ICH, ISO 13485, ISO 14155, Good Clinical Practices (GCP), and regulatory guidelines from the world's leading health agencies.
Languages and Regions
Do you offer services in other languages?
Yes. We offer services in Spanish, English, and Mandarin Chinese, serving projects in North America, Latin America, Europe, and Asia.
Can you work with companies outside of Mexico?
Yes. We work with international clients seeking to enter the Latin American market or requiring regulatory support in multiple regions.
Do you offer a free initial consultation?
Yes. We provide a free initial assessment, where we review your case and define the next steps.
How can I request a quote?
You can do so through the contact form on our website, via email, or through our corporate WhatsApp. A specialist will respond within 24 hours.
