We work based on the following steps:

Regulatory Gap Analysis & Requirements Harmonization
We evaluate your existing documentation and processes against local regulatory frameworks to identify gaps, overlaps, and inconsistencies across jurisdictions. From this analysis, we design a unified strategy to harmonize technical and administrative requirements, ensuring consistent and compliant submissions throughout Latin America while reducing duplication of effort, time, and cost.

Dossier Compilation
We compile, structure, and submit complete regulatory dossiers in alignment with each authority’s standards, streamlining the approval process and accelerating time-to-market.

Labeling and Claims Compliance
We review, adapt, and validate labeling, packaging, and product claims to guarantee full compliance with national regulations while maintaining brand integrity and consistency.

Quality Management Systems (QMS)

Our QMS services enhance compliance and operational excellence by integrating regulatory expertise with industry best practices. We design and implement Quality Management Systems aligned with internationally recognized standards and guidelines applicable to pharmaceuticals, medical devices, and cosmetics. Our support covers system development, documentation, internal audits, and staff training. By evaluating existing processes, identifying gaps, and recommending corrective and preventive actions, we help your organization achieve continuous improvement and maintain full readiness for inspections and certifications.

Compliance:

We provide a full suite of compliance services designed to meet the highest regulatory standards and strengthen your organization’s operational integrity. By conducting in-depth risk and context analyses, developing tailored policies and procedures, and implementing targeted compliance initiatives, we build robust and sustainable frameworks.

Our team is led by seasoned experts, including an international speaker and Lead Auditor in risk-based management systems certified by the UK IRCA body, and a specialist in implementing international management and compliance standards (ISO 9001 and ISO 37301). With over fifteen years of experience in anti-money laundering, counter-terrorism financing, crime prevention, risk management, and compliance, our experts bring unparalleled insight to every project.

We understand compliance as the set of procedures and best practices adopted by organizations to identify, classify, and mitigate operational and legal risks. Our services also include staff awareness and training programs to ensure compliance principles are embedded across all levels of the organization, reducing risk and fostering a culture of accountability and continuous improvement.