Marketing Authorization (MA)

Certificates of Analysis

Good Laboratory Practices (GLP)

Good Manufacturing Practices (GMP) Certificates of Pharmaceutical Products (CPP) Agreements

Common Technical Document (CTD)

Investigational Medicinal Product Dossiers (IMPD)

Bioequivalence Studies

Stability studies

Pharmacokinetic and pharmacodynamic studies

Physicochemical, biological and microbiological studies

Pharmacological and toxicological studies

Drug Master File (DMF)

Site Master File (SMF)

Material Safety Data Sheet (MSDS)

Pharmacovigilance Reports

Instructions for use (IFU)

In vitro diagnostic tests in microbiology, immunoassays and molecular biology New Drug Application (NDA)

Official Mexican Standards (NOM)

Validation Master Plans (VMP)

Standard Operating Procedure (SOP)

Protocols