KIRA Regulatory Affairs Solutions

Regulatory Solutions for a Safer LATAM Market

About KIRA

We provide regulatory affairs solutions in LATAM, supporting submission processes and life‑cycle management for pharmaceutical products across the region. We also offer direction, guidelines, and requirements to obtain licenses and register your products.

At Kira Regulatory Affairs Solutions, we provide comprehensive regulatory affairs solutions for the pharmaceutical industry in Latin America. We support our clients throughout the processes of product registration, licensing, and life cycle management, ensuring regulatory compliance in the countries in the region, with an agile, precise, and results‑oriented approach.

To be the leading company in regulatory solutions for the pharmaceutical industry in LATAM, recognized for our technical excellence, commitment to quality, and ability to simplify and optimize our clients’ path toward the approval and maintenance of their products in the market.

To provide comprehensive and specialized regulatory affairs solutions for the pharmaceutical industry in Latin America, ensuring regulatory compliance and facilitating the safe and timely access of products to the market.

  • Support clients throughout the entire process of product registration, licensing, and life cycle management in Colombia, Uruguay, and other countries in the region.
  • Develop and maintain an up‑to‑date portfolio of services that meets the regulatory needs of LATAM markets.
  • Ensure compliance with local and international regulations, minimizing regulatory risks for clients.
  • Provide specialized technical advice to guide clients in the interpretation and application of regulatory requirements.
  • Optimize internal processes to deliver agile, precise, and results‑oriented services.
  • Strengthen strategic partnerships with regulatory agencies, laboratories, and local partners to expand service reach and efficiency.

Service Portfolio

Marketing Authorizations

  • Medical devices (Classes I–III), biological and synthetic products.
  • Dietary supplements and personal care, hygiene & cleaning products.
  • CTD/eCTD dossier preparation, labeling and promotional material checks.
  • Regulatory intelligence and LATAM due diligence.

Life‑Cycle Management

  • Renewals, variations and line extensions.
  • MAH transfers, label updates and IFUs.
  • Tech transfers and manufacturing site changes.
  • Support during regulatory inspections and audits.

Training & Strategy

  • Team training on LATAM regulatory frameworks.
  • Registration roadmaps, timelines and filing strategies.
  • Engagement with authorities and local partners.
  • Sustainability advisory for packaging and responsible labeling.

Compliance & Quality

  • GAP assessments vs. local & international requirements.
  • GMP/ISO readiness and documentation support.
  • Document harmonization.

Corporate Values

Integrity and transparency.

Tailored and effective solutions.

Optimization and agility.

Sustainable, responsible practices.

A respectful, equitable workplace.

Work with authorities and partners.

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