Licensing

Tecnología Innovativa has strong and trusting bonds with leading companies in the Argentine and Latin American pharmaceutical market and a proven track record in generating successful agreements of licensing with subsequent successful product launches.

Marketing

Tecnología Innovativa has a strong force in Argentina and Latin America by partnering with local companies. Our partners and distributors are mature organizations which provide integral support for companies looking to enter LATAM market. This includes:

• PRE MARKETING ASSESMENT: Definition of accurate market conditions and choosing the right products to maximize competitive presence.
• OPTIMIZING REGULATORY TIMEFRAMES: Providing regulatory support and working with local authorities to register the products.
• LAUNCH READINESS: Strong force and distribution networks to penetrate the market.
• PROFIT EFFECTIVENESS AND METRICS: Regular updates and complete transparency to ensure better margins.

Description of services we provide:

1. Instrumentation of the Pharmacovigilance service to receive all reports of adverse event notifications related to the Laboratory's products. This service includes the availability to receive calls from 9 to 18 hours from Monday to Friday and a mobile phone for emergencies for contact outside the aforementioned working hours.
2. Preparation and sending of the reports received to the regulatory authorities in accordance with the provisions of the Pharmacovigilance good practice provision.
3. Bibliographic searches.
4. Drafting of IPAS (PSUR) and PGR (RMP).
5. Support for answering the requirements of the regulatory authority on problems related to the pharmacovigilance of the products.
6. Follow-up of the risk management plans proposed for the products.
7. Drafting and execution of Effectiveness and Safety Monitoring Plans (PMEEs) and Post-Approval Safety Studies (PASS).

Tecnología Innovativa, are currently working together with academics centers to promote research, diagnosis, and development of new treatments, focusing on treatments for people with rare genetic diseases of low incidence, or special treatments of low incidence and high cost.

Together, they offer the possibility to pharmaceutical companies, currently working in the research and development of drugs for rare and special therapeutic areas, of support and knowledge to be introduced at the Latin American market, through local research, promotion of diagnosis, and selection of local partners who can enhance and facilitate the launch of new Specialty Products.

Tecnología Innovativa S.A. is dedicated to providing solutions to the pharmaceutical industry. We offer a range of services tailored to their needs, focusing on clinical studies of bioequivalence, bioavailability and pharmacokinetics, and in vitro biowaivers of In Vivo Bioavailability and Bioequivalence Studies (using cultured epithelial cell monolayer) ( *FDA, 2000. Guidance for industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms based on Biopharmaceutics Classification System. US Food and Drug Administration, Center for Drug Evaluation and Research, USA).

We have a team of academic experts in Medical Pharmacology of the School of Medicine, University of Buenos Aires, national reference center in pharmacology. We have a strong interdisciplinary group of professionals with extensive experience in clinical research, basic research and analytical techniques, including medical doctors, molecular biology and biochemistry, all specializing in pharmacology.

Clinical trials and bioequivalence studies

Clinical trials and bioequivalence studies are conducted according to the regulations established by ANMAT and in compliance with good clinical practice guidelines (defined in ICH E6: Guideline for Good Clinical Practice), Declaration of Helsinki and the Nuremberg Code. Clinical research is conducted at a private hospital of high complexity, in which we have an area reserved for healthy volunteers, an area of hospitalization and adult intensive therapy of high complexity, surgery rooms equipped with the latest technology and a very prestigious team of medical professionals.

The bioanalytical quantification phase is developed in specialized centers ANMAT certified and with extensive experience in the field.

DOSSIER ASSEMBLY SERVICES: Our team has extensive experience in the bibliographic assembly of modules 4 and 5 of the Dossier for registration in CTD format.