Our mission is to provide high quality services, transmitting 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 pharmaceuticals companies willing to expand their businesses across Latin america.
Our values frame our company culture and define the behavior we expect from our team.
We are constantly looking for opportunities in countries with high sanitary surveillance that do not have an organic presence in Latin America. To do this, we have a network of 40 pharmaceutical companies in the region who delegate to us their search for new businesses (products, lines, subsidiaries, technologies, etc.)
Our Development and Regulatory Affairs area is very robust and works in mirror with the respective teams of our clients, improving their productivity and time to market.
Our active presence in Latin America, Asia and Africa regularly brings us business opportunities and unsatisfied needs. To date we have accompanied our clients in commercial operations in more than 40 markets, with all commercial, regulatory and legal support.
The international pharmaceutical industry is very dynamic and our commercial and technical presence in the different markets opens up a permanent scenario of buying and selling opportunities for companies, plants and product lines. We have the support of companies specialized in international transactions, adequate to provide the legal, financial and regulatory framework for each transaction.
As part of the identification of the dynamism of the needs of our clients, today we also support them in administrative tasks such as monitoring of SEDRONAR, Pharmacovigilance, Risk Management Plans, Post-registration modifications, Re-registrations, Updating of prospectuses, etc. either to comply with local regulations or to satisfy international requirements.
As part of the global service, we provide support in the Quality area such as the drafting of the Quality Manual, Programs, Site Master File, Standard Operating Procedures, drafting of analytical validation protocols, Process, Annual Product Review (APR).
We are a team with a long history in the industry, in development, in 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 licenses of exclusive innovative products that are currently marketed in different markets, leading all legal, administrative and commercial processes to successfully complete these procedures.
We have brought to the region more than 100 special generic products, either due to their innovative technology, their differential presentation or their documentary strength (US / EU / JAPAN / AUSTRALIA / CANADA) which enabled local companies to significantly improve their speed registration and its commercial performance.
We have carried out 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.
Industrial Engineer, with +25 years of experience in Business Development, Sales, Operations, F&A and Strategy, both in global corporate positions and startups. Some of these companies are PINT PHARMA, CRISTALIA, GLENMARK, GIVAUDAN and SERONO, which forged his professional experience in various areas, integrating biotechnology, innovative cancer therapies, genetic disorders and global generic portfolios. Flexibility, adaptability and changing environments have always been his biggest challenges
Pharmaceutical Professional, with +20 years of experience in Regulatory Affairs, Product Development and Plant Technical Management, both in multinational and national companies.
In the last 10 years she leaded regional registration processes of innovative medicines, vaccines, and complex generics, successfully approving very strict international audits, and managing IP protections against local copies, working together with specialized lawyers.