DEVELOPMENT
AND VALIDATION
Of analytical methods for active pharmaceutical ingredients (APIs) and drug products (special expertise in the research of genotoxic impurities) to control the quality and stability of products and prepare registration dossiers.
STABILITY
STUDIES
Stress testing and definition of degradation profiles, studies at 5°C, 25°C/60% RH, 30°C/65% RH, 30°C/75% RH and 40°C/75% RH on active pharmaceutical ingredients (APIs) and drug products to control the quality and stability of products in registration phase and already on the market.
PRODUCT
CHARACTERIZATION
AND BATCH RELEASE
TESTING
According to pharmacopeial monographs or in-house methods via analytical transfer for small molecules, macromolecules and biotech products (APIs, excipients and drug products).
ISOLATION AND
IDENTIFICATION
Of unknown impurities by MS, NMR and the use of enriching techniques and preparative chromatography as well as laboratory-scale synthesis to prepare standards for the control of pharmaceutical products.
STUDIES ON
EXTRACTABLE
AND LEACHABLE
COMPOUNDS
To ensure product quality and patient safety. Includes analysis based on PQRI indications and USP requirements and toxicological evaluations (OINDPs, PODPs Topical DPs, biodisposables and Single Use Systems). Pharmacopeial testing on containers and closures.
MICROBIOLOGICAL
TESTS
For unspecified and specified microorganisms: development and validation of analytical methods, microbial identification, microbiological assay of antibiotics, efficacy of antimicrobial preservation, disinfectant efficacy studies, microbiological environmental monitoring, microbiological integrity of packaging materials.

BIOANALYTICAL
TESTING
For animal and human PK or bioequivalence; metabolites identification studies and synthesis of metabolites.