Activation Laboratories Ltd. services

Validation of an analytical procedure is an essential process in the GMP analysis of a pharmaceutical product.  This can include Limit tests for the control of impurities and  quantitative tests of the active in drug products.  Validation parameters as set out by the International Committee on Harmonisation (ICH) are followed.Assay, Impurity and Stability Indicating methods utilizing techniques such as  HPLC, LC/MS, GC, GC/MS, ICP/OES, ICP/MS and Ion Chromatography are available.

R&D Applications: Crystal structure determination by powder X-ray diffraction. Polymorph screening. Patent investigation and comparison.

Pharmacopeial monographs such as the US Pharmacopeia-National Formulary (USP/NF), the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), and the British Pharmacopoeia (BP) provide standardized methods and specifications for generic pharmaceutical raw material and finish products.  Certificate of analysis (C of A) for raw material and products are provided.

Actlabs Biotech and Bioanalytical scientists employ a variety of platforms to assist with analysis of proteins, peptides and antibodies. Actlabs Biotechnology will continue to add to our portfolio of technologies available for Protein analysis. Current methods and techniques include :

Actlabs Biotech Scientists, in conjunction with our Bioanalytical Research staff  employ a variety of techniques in order to develop, validate  and conduct many different bioanalytical sample analyses. Working with either Pre-clinical or Clinical study Directors, Actlabs staff will utilize existing in-house methods or will develop appropriate bioanalytical methods, validate the methods if required ( GMP/GLP) and proceed to sample analysis.   Biological matrices include blood, serum, plasma, tissue, CSF, organs, urine, feces and body fluids. Bioanalysis of small molecule and large molecule drugs,  metabolites and biomarkers in both animal and human matrices. Bioanalytical techniques available include: