With 35 years of experience, AMIC specializes in designing and conducting clinical trials for the pharmaceutical industry in Mexico and abroad. In addition to conducting studies, we provide comprehensive consultancy in clinical research at every stage.
Authorized Third Party
AMIC holds Authorization No. TA-73-21 to conduct bioequivalence studies.
This service includes everything from proposing the clinical study, designing the research protocol, informed consent, and case report forms to delivering final medical and pharmacovigilance reports.
For the execution of this service, AMIC has a bank of healthy volunteers and all the documentary and regulatory support required by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
The success of our laboratory is largely due to our highly qualified and dedicated team of researchers.
Our researchers come from various disciplines and have extensive experience in both academic and industrial research.
We are committed to the professional and personal development of our team, fostering a collaborative and supportive work environment.
Carry out studies of bioavailability, efficacy, safety and other clinical research services, in accordance with current regulatory provisions and good clinical practices; within an efficient quality management system, which ensures the satisfaction of the needs of our clients and the commitment to the continuous improvement of our services.
AMIC establishes, implements, maintains, and continuously improves its Quality Management System, including the necessary processes and their interactions, in accordance with the requirements of the ISO 9001:2015 / NMX-CC-9001-IMNC-2015 quality standard.
The conduct of clinical studies by AMIC is certified under the ISO 9001:2015 quality standard.
The quality management system is applicable to 4 lines of services that AMIC offers:
A. Conducting (including document design and execution) bioavailability and bioequivalence studies.
B. Conducting studies from Phase I to IV.
C. Coordination of clinical research studies (may include document design) conducted at clinical sites external to AMIC.
D. Consultancy and training (including audits, monitoring, clinical research training, and general consultancy).
Carry out studies of bioavailability, efficacy, safety and other clinical research services, in accordance with current regulatory provisions and good clinical practices; within an efficient quality management system, which ensures the satisfaction of the needs of our clients and the commitment to the continuous improvement of our services.