Pkinetix Latin AmericaPKINETIXLATIN AMERICA Get in touch

Your regulatory and clinical partner in Latin America

We help pharmaceutical, biotech, medical device and diagnostics companies register products, run studies and set up operations across more than 30 countries, from Mexico to Argentina.

Talk to us about your project See our services
Markets we coverMore than 30 countries
  • ANVISABrazil
  • COFEPRISMexico
  • ANMATArgentina
  • INVIMAColombia
  • ISPChile
  • DIGEMIDPeru
  • ARCSAEcuador
  • AGEMEDBolivia
  • MSPUruguay
  • DNVSParaguay
  • DNFDPanama
  • ARNCosta Rica
  • DIGEMAPSDominican Republic
  • DNMEl Salvador
  • DRCPFAGuatemala
  • ARSAHonduras
  • DGRSNicaragua
  • CARPHACaribbean
  • 17 national authorities, plus the 15 CARICOM member states served by CARPHA's Caribbean Regulatory System.

Regional coverage

One point of contact for more than 30 countries, with local experts on the ground in each market.

Industry know-how

We know the regulatory, clinical and commercial realities of each market and how business gets done there.

Since 2014

More than a decade supporting global sponsors with regulatory, clinical and safety work in the region.

Services

Open any service to see what it includes. Most projects combine several of them, coordinated by a single Pkinetix program manager. We have particular experience with orphan drugs, biosimilars, and cell and gene therapies.

Regulatory documents

Regulatory affairs

Product registrations, clinical trial applications and agency meetings across the region.

Registrations and regulatory strategy
We explain what each national authority currently requires for your submission and what you need to meet it, then coordinate dossier preparation and submission with our in-country partners.
  • New product registrations and CTA submissions
  • Variations, new formulations, new indications and line extensions
  • Meetings with regulatory authorities
Expedited pathways and special designations
Orphan drug, pediatric rare disease, fast track and breakthrough designations, and humanitarian use exemptions, where each country offers them.
Biosimilars
Biologic manufacturing
  • Dossier assembly, submission and defense
  • Manufacturing and tech-transfer support
  • PDP negotiation in Brazil
  • Phase I to III trials and PK studies for biosimilars
Cell and gene therapies
Cell and gene therapy researchCell and gene therapies follow their own rules in each country. We help you understand them, prepare dossiers and coordinate meetings with agencies.
Drug safety review

Drug safety and pharmacovigilance

Safety work led by people with hands-on pharmaceutical industry pharmacovigilance experience.

Case processing and reporting
  • Individual case safety reports (ICSRs)
  • Aggregate reports: PSURs, PADERs and DSURs
  • Literature search
Risk management and signal detection
  • Risk management plans and REMS
  • Signal detection and management
Clinical trial safety
Safety management for studies running in Latin America, aligned with local reporting requirements.
Clinical trial

Clinical research

CRO selection and oversight so you have eyes and ears on the ground during your study.

Phase I to IV clinical trials
Feasibility analysis, CRO selection and budget negotiation, country-by-country regulatory review, protocol and documentation support, ethics committee and agency submissions, study oversight and final reports.
BA/BE and PK/PD studies
  • BA/BE studies, fasting and fed
  • BE studies for drug combinations
  • PK/PD studies and PD studies for hormones and biomarkers
  • Mathematical modelling of PK data
Rare disease recruitment support
Patient careWe help rare disease sponsors identify sites, specialists and patient organizations in the countries where their patients are.
Business meeting

Partnering and market entry

Find partners and get established in the region.

Licensing and partnering
In-licensing and out-licensing support, with a focus on biosimilars and orphan drugs, plus identification of distributors and commercial partners.
Market entry support
Market intelligence before you commit, then coordination with local legal, accounting and HR firms once you decide to set up in a country.
  • Pre-entry market intelligence
  • Partner and distributor scouting
  • Entity setup and compliance through local firms

How we work

You work with one Pkinetix program manager. We bring in vetted local specialists in each country and keep the whole project on one plan, one budget and one timeline.

Clinical research team at work

  1. Assess

    We review your product, goals and target markets, then map the requirements, timelines and costs for each country.

  2. Coordinate

    We select and manage the right local partners, CROs and advisors, and handle communication with authorities and ethics committees.

  3. Deliver

    We track every country against the plan, report progress in English, and hand over complete documentation at the end.

About Pkinetix

Pkinetix is a New Haven, Connecticut based consultancy focused on Latin America, working with global sponsors since 2014.

Our mission is to help pharmaceutical, biotechnology, medical device, diagnostics and healthcare companies from around the world succeed in a region of more than 650 million people.

Our team has held senior roles at multinational companies in the United States, Europe and Latin America, so we understand both what global sponsors expect and how business gets done in each local market.

Tell us about your project

Share a few details about your product and target countries, and we will get back to you.

Office
59 Elm St., Suite 200
New Haven, CT 06510, USA

Please don't include confidential information yet. We can sign a CDA before you share details.