Analytical excellence with international standard infrastructure
We perform advanced analyses with high precision and traceability, supported by a robust LC-MS/MS park and state-of-the-art chromatographic and physicochemical techniques.
We meet the requirements of ANVISA, FDA, and EMA, ensuring consistent methods, accurate timelines, and reliable data for development, registration, and quality control.
Development and Validation of Analytical Methods
We create and validate robust and specific analytical methods, ensuring precision, accuracy, and reproducibility for complex pharmaceutical analyses.
The methods are structured and validated according to RDC No. 166/2017 and applicable ICH guidelines, with evaluation of various parameters.
Development of Methods for Dissolution
We developed dissolution methods in accordance with RDC No. 31/2010 and Guide No. 14/2021, applicable to different release profiles.
We have apparatus I, II, and III, including the latter, specifically for the development of methods aimed at modified release pharmaceutical forms.
Solubility Study Shake-Flask
Solubility studies using the shake-flask method, in accordance with RDC No. 31/2010 and Guideline No. 14/2021, to evaluate the solubility of drugs under controlled conditions, considering different media and relevant pH ranges for biopharmaceutical development and classification.
Study of Forced Degradation
We conducted a prediction study of degradation and analytical evaluation according to RDC No. 964/2025 and Guide No. 79/2025.
Forced degradation studies aim to characterize the degradation profile of the active pharmaceutical ingredient or the finished product when subjected to stress conditions.
Extractable and Leachable (E&L)
We developed the analytical strategy and carried out the instrumental execution of extractable and leachable studies, according to ICH Q3E guidelines, allowing us to identify the chemical profile of materials under stress conditions and evaluate the possible migration of compounds to the product under simulated storage conditions.
Elementary Impurities
We carried out the determination of metals and elemental impurities by ICP-MS, in accordance with the limits established by ICH Q3D, supporting the assessment of risk and the control of inorganic contaminants in raw materials and finished products.
Study of Nitrosamines
We develop and execute the analytical strategy for the control of nitrosamines and determination of nitrite as a possible precursor, according to RDC No. 677/2022 and Guide No. 50/2021. The quantification of the substances is performed using LC-MS/MS and GC-MS/MS.
Process Validation and Cleaning (Analytical Stage)
We operate in analytical support for process validation and cleaning, through the detection of residues and the assessment of the consistency of production stages.
The studies demonstrate control of processes and mitigation of cross-contamination risks, in accordance with RDC No. 658/2022 and IN No. 138/2022.
Quality Control Services – REBLAS
RDC No. 928 of 09/25/2024 and RDC 512 of 2021
The largest analytical park in Latin America for mass spectrometry
Our modern facilities include state-of-the-art equipment, such as:
Validated infrastructure and global compliance
Our facilities meet international quality and safety standards, ensuring the credibility of every result delivered.
Pharma Solutions
Integrated solutions for the pharmaceutical industry
From clinical research to laboratory analyses and regulatory studies, our Pharma solutions connect all the necessary steps for the development, validation, and registration of medications.
