Developing high quality pharmaceutical products is the challenge driving us.
To achieve this, we must go beyond the pharmaceutical quality of our products and comply with the latest demands for efficacy and safety, through:- Bioequivalence studies
- Interchangeability and biosimilarity demonstration for biotech products
- Safety and efficacy clinical studies
- Pharmacokinetic-pharmacodynamic studies, for complex non-biological products (CNBP)
- Pharmacovigilance management
- Product documentation and updated information
Pharmacovigilance
Tracking the use of our products allows us to guarantee their reliability and safety once in the market. Thus, we promote the safe, effective and sensible use of drugs. To do this, we provide updated information on the use, indications and safety of our products.
We know how to listen
Through the Inter-American Monitoring Center (CIM) we centralize our pharmacovigilance service. This site allows healthcare professionals and patients to document any kind of inconvenience with their use. Our objective is to early detect the appearance of adverse reactions, medication errors, falsifications or adulterations, uses beyond the approved indications, use in pregnant or breastfeeding women, lack of efficacy, and drug abuse.
A unique report management system in Latin America
To simplify case management, we have created a web platform available at www.cimlatam.com. Each case is handled anonymously and confidentially, maintaining the privacy of personal data.
We take care of people
Each member of our company is trained to provide precise guidance to physicians and patients on the procedures to follow when they suspect of any adverse reaction.
The most up-to-date medical information
We believe it is our obligation to provide physicians and patients with the most up-to-date information on the products they use.In order to provide physicians and patients with the most up-to-date information on our products, we have information from high health surveillance agencies, as well as global scientific literature and aggregated reports on pharmacovigilance. In addition, this information complies with the national requirements of the countries where we market our products.
Bioequivalence
Megalabs aims at having medicines, not only of the highest quality, but also to ensure predictable therapeutic results. To do this, we carry out bioequivalence studies, comparing plasma concentrations and pharmacokinetic parameters of our products and those of reference worldwide. Our policy of developing bioequivalence products is one of the pillars of our leadership.
Bioequivalence and pharmacovigilance: one objective
At the intersection between bioequivalence and pharmacovigilance we find the explanation for the therapeutic failure or success of any product.Our organization carries out an average of 40 annual bioequivalence studies, which comply with the international regulations of Good Clinical Practices, the latest ethical regulations, and the guidelines of the local Health Authorities and high health surveillance agencies.
Pre-clinical studies
We carry out pre-clinical studies to determine the pharmacokinetic and pharmacodynamic profile, therapeutic effect and toxicity in animals of our products. These studies demonstrate its safe use in the subsequent clinical studies.
