Fast-Tracking First-in-Human Trials, Anywhere

Accelerated Medtech and Biopharma Clinical Study Services

Medtech, Biopharma, and Radiopharma early-phase clinical trials require high experience, specialized knowledge, and flexibility. When you trust the outcome of your trial with us, you leverage a team of experts with a proven background of 15+ years.

Our sole focus is managing early-phase clinical studies through to success. bioaccess® has the expertise and customized approach you need to navigate your company towards an acquisition.
Start Your Trial 40% Faster

Our Service Capabilities for Clinical Studies Include:

  • Viabilidade e seleção do local de pesquisa e do pesquisador principal (PI).
  • Revisão e feedback sobre os documentos do estudo para atender aos requisitos do país.
  • Trial set-up, start-up, and regulatory approval (institutional review board, ethics committee and health ministry).
  • Import permit and nationalization of investigational products.
  • Estudar o gerenciamento e o monitoramento de projetos.
  • Relatórios (status do estudo, inventário, eventos adversos graves e não graves).

Market Access Services for Latin America: Accelerate Entry into Mexico, Brazil, Colombia,Peru & Chile.

Unlock Latin America’s $11B MedTech & Biopharma Market with bioaccess®’s End-to-EndMarket Access Solutions

Why Choose bioaccess®?

15+ Years of Experience | 100+ Startups Accelerated | 40% Faster Approvals vs. US/EU
We cut through Latin America’s regulatory complexity so you can focus on innovation. From COFEPRIS approvals in 6 weeks to ANVISA’s new foreign-assessment pathways, we turn fragmented processes into streamlined market entry.

Core Services:

Regulatory Strategy & Registration

  • Secure approvals 50% faster with localized expertise.
  • Device/Pharma Classification: Navigate Mexico’s COFEPRIS (Class I-III), Brazil’s ANVISA (RDC185), and Colombia’s INVIMA.
  • Dossier Preparation: FDA/EMA-aligned technical files + country-specific adaptations (e.g. DIGEMID GMP for Peru).
  • Local Representation: We act as your Mexico Registration Holder (MRH) or Brazil’s Responsável Técnico – no need for costly local entities.
  • Expedited Pathways: Leverage Brazil’s new Normative Ruling 289/2024 to fast-track approvals via FDA/EMA reliance.
  • Key Differentiator: Pre-validated templates for Mexico’s CTN, Chile’s ISP 2-3 month approvals, and Peru’s DIGEMID Sanitary Registrations.

Reimbursement & Health Economics

  • Maximize pricing and coverage in public/private systems.
  • CONITEC/Brazil: Budget-impact models for SUS (Unified Health System) inclusion.
  • Colombia/Peru: Navigate low reimbursement rates (10% for innovative therapies) with value-based pricing strategies.
  • Chile FONASA: Optimize GRD-adjusted payments for inpatient devices.
  • Key Differentiator: Pre-validated templates for Mexico’s CTN, Chile’s ISP 2-3 month approvals, and Peru’s DIGEMID Sanitary Registrations.
  • Private Payer Negotiations: Target top insurers like SURA (Colombia) and Grupo Nacional (Mexico).
  • Case Study: Slashed 9 months off a digital health startup’s FONASA reimbursement timeline via GRD alignment.

Market Research & Commercialization

  • Avoid costly missteps with data-driven insights.
  • Patient Access Mapping: Identify treatment-naive populations (e.g., Colombia’s rare disease clusters).
  • Competitor Benchmarking: Analyze pricing for Class III devices in Mexico’s $1.2B market.
  • Distributor Partnerships: Access our vetted network across 50+ LATAM sites.
  • E-Billing Compliance: Implement Colombia’s Resolution 000008 and Mexico’s e5cinco systems.
  • Toolkit Included: Interactive pricing calculators, reimbursement rate databases, and cultural training modules.

Post-Market Support

  • Stay compliant, competitive, and scalable.
  • Amendments/Renewals: Mexico’s COFEPRIS administrative updates in <4 weeks.
  • Vigilance Reporting: Adverse event management per ANVISA RDC 67/2023.
  • COFEPRIS Audit Prep: Mock inspections aligned to ISO 13485:2016.
  • E-Billing Compliance: Implement Colombia’s Resolution 000008 and Mexico’s e5cinco systems.