Regulatory Affairs

Pkinetix regulatory affairs consultants have the experience to take a broad view of the pharmaceutical process.

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Clinical Research

Pkinetix performs country by country analysis of regulatory requirements for the execution of your clinical study in LATAM.

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Pharmacovigilance

Pkinetix can provide a wide range of drug safety and pharmacovigilance services to support your venture at Latin America.

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Business Development & Licensing

Our BD team is focused on getting the job done to help you grow your business and generate revenue in the region.

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Biosimilars

Our firm understands  the region’s uneven patchwork of regulatory frameworks, the complexities of each local market  and puts this knowledge to work for you.

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Intellectual Property

Pkinetix partners with the most reputable intellectual property firms in Latin America to help our customers protect their IP in different countries in the region.

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M&A

Pkinetix partners with leading financial services firms across the region to help our customers meet their financial needs.
We connect the dots for you and provide the handholding necessary to get the job done, on time and on budget.

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Latin Expansion Support

Pkinetix team members understand how business gets done globally and particularly in Latin America because they know the business cultures in the region and have worked as high-level executives at leading multi-national firms in the USA and Europe as well as LATAM.

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Lifecycle Management

Pkinetix provides customer-centric lifecycle management services that offer customized, cost-effective solutions to drug companies seeking to expand into Latin American markets. We can help to maximize your company’s business potential in the region.

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Cell and Gene Therapy Services

Pkinetix’s regulatory team can help your firm navigate current regulations and guidelines that exist specifically for cell and gene therapies in Latín America.

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Rare Disease Recruitment Support

Pkinetix helps rare disease companies to meet their recruitment objectives by leveraging our strong relationships with leading metabolopathy KOLs, scientific associations and patient advocacy groups across Latin America.

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BE Studies

Pkinetix provides a wide range of services for Bioequivalence and Bioavailability studies.

We can help our clients design and conduct their studies successfully.

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