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Our mission is to provide high-quality services, conveying to the client respect, experience, and reliability acquired throughout an extensive trajectory.
Through our team and our global network of contacts, we aim to be the perfect partner for pharmaceutical companies looking to grow in the Latin American region.
Our values frame our company's culture and define the behavior we expect from our team.
We constantly seek opportunities in countries with high health surveillance that don't have an organic presence in Latin America. For this, we have a network of 40 pharmaceutical companies in the region who delegate their search for new business to us (products, lines, subsidiaries, technologies, etc.).
Our Development and Regulatory Affairs area is very robust and works in mirror with our clients' respective teams, improving their productivity and time to market.
Our active presence in Latin America, Asia, and Africa regularly brings us commercial opportunities and unmet needs. To date, we have accompanied our clients in commercial operations in more than 40 markets, with all the commercial, regulatory, and legal support.
The international pharmaceutical industry is very dynamic, and our commercial and technical presence in different markets opens up a permanent scenario of opportunities for buying and selling companies, plants, and product lines. We have the support of companies specialized in international transactions, suitable to provide the legal, financial, and regulatory framework for each transaction.
As part of identifying our clients' dynamic needs, we now also support them in administrative tasks such as SEDRONAR monitoring, Pharmacovigilance, Risk Management Plans, Post-registration Modifications, Re-registrations, Prospectus Updates, etc., whether to comply with local provisions or to meet international requirements.
As part of the global service, we provide support in the Quality area such as drafting Quality Manual, Programs, Site Master File, Standard Operating Procedures, drafting analytical validation protocols, Process, Annual Product Review (APR).
We are a team with extensive experience in the industry, in development, regulatory affairs, and international business. We also have a network of professionals in the region who actively collaborate in local regulatory processes.
We have brought to the Latin American region almost 30 exclusive innovative product licenses that are now marketed in different markets, leading all legal, administrative, and commercial processes to successfully complete these operations.
We have brought to the region more than 100 special generic products, whether due to their innovative technology, differential presentation, or documentary solidity (US/EU/JAPAN/AUSTRALIA/CANADA), which enabled local companies to significantly improve their registration speed and commercial performance.
We have completed more than 400 pharmaceutical developments for the region and converted more than 150 local dossiers to CTD and aCTD formats.
We have successfully completed 7 M&A operations in the region.
Pharmaceutical industry executive with +25 years of experience in Business Development, Sales, Operations, Finance and Administration, and Strategy, both in global corporate positions and startups. Some of these companies are PINT PHARMA, CRISTALIA, GLENMARK, and SERONO, which forged his professional experience in various areas, integrating biotechnology, innovative oncological therapies, genetic disorders, and global generic portfolios. Flexibility, adaptability, and changing environments have always been his greatest challenges.
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Pharmaceutical Professional with +20 years of experience in Regulatory Affairs, Product Development, and Technical Plant Management, both in multinational and national companies.
In the last 10 years, she has led registration processes in the region for innovative drugs, vaccines, super generics, approving the strictest international audits, and managing regulatory and legal processes for intellectual property protection, together with specialists in the field.
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