Testing and Regulatory
Developing methods and characterizing products
Developing, validating, transferring or applying analytical methodologies all provide significant support for R & D project delivery, as well as to the pharmaceutical industry.
We have a Health Canada Drug Establishment Licence, attesting to the high quality of our development of methods and testing. Our team has considerable expertise in complementary disciplines such as analytical chemistry, microbiology, biochemistry, and cellular and molecular biology. Therefore, we are able to develop methodologies to characterize active ingredients and the quality control required to develop products, study stability and assess purity.
Specifically, we are able to quantify active substances, impurities, and organic and inorganic contaminants as well as to conduct forced degradation studies, identifying and quantifying microbial contaminants in various types of products.
We also characterize microbial organisms, whether it be through traditional microbial enumeration techniques or by applying molecular biology or genomic techniques.
Through our facilities and analytical capabilities, we also conduct stability studies according to established protocols. We offer this type of monitoring for pharmaceutical products, natural health products, cosmetics and some food products. This stability testing is performed taking into account the specific conditions of long-term, intermediate and accelerated studies (ICH), for the various climatic zones associated with different products.
We leverage our capabilities in developing methods for analytical chemistry, microbiology, biochemistry, and cellular and molecular biology to support industrial R & D projects and marine biotechnology research projects. We have also developed considerable expertise in the analysis of marine biomass products.
These development projects have led to the following concrete examples: pharmaceutical assets and finished products, natural health products, plastics, foods, biomasses (marine, forestry and agricultural), cosmetics, pesticides, algal toxins, colouring agents, and preservatives.
Meeting regulatory requirements
In an increasingly demanding regulatory environment, we can help you get your products to market more quickly.
Our quality assurance (QA) and quality control (QC) team, working collaboratively with our scientific team, provides you with individualized support throughout the following stages:
- Guidance and technical and scientific assistance for ongoing innovation;
- Guidance and regulatory assistance ensuring target market regulatory requirements are applied;
- Conducting technical and scientific investigation for the submission of regulatory files;
- Preparing regulatory files (product monograph, specification, licensing file, etc.);
- Technical, scientific and regulatory training in business and industry settings.