Med-Script Regulatory Affairs and eCTD Preparation for Drug Submissions
Med-Script supports a wide range of regulatory submissions for drugs, medical devices and clinical trials. It consists of two sister companies, Med-Script Associates and Med-Script Development.
Med-Script Associates prepares, files and supports clinical trial and drug applications, including submissions for new drugs, biologics, generics, natural health products and medical devices, while Med-Script Development is experienced in electronic common technical document (eCTD) preparations for drug submissions, utilising its own fully validated eCTD software.
The companies also help ensure regulatory compliance in research and development (R&D) processes, including good manufacturing practice (GMP) evaluations, product sourcing, liaising with contract research organisations (CRO), gap analysis, pharmacovigilance reporting and planning of Phase I, II and III development.
Regulatory affairs for drug submissions
Med-Script offers comprehensive services for pharmaceutical R&D, drug submissions to national regulatory agencies, and validated eCTD preparation.
Med-Script Associates has helped pharmaceutical companies worldwide to submit successful applications for innovative drugs and biologics, as well as abbreviated new submissions for generic medications, supplements and medical devices.
Med-Script Development utilises a high-quality software that was developed in-house. The company has successfully filed numerous submissions electronically for clients, providing significant cost savings compared with other eCTD suppliers.
The specialised software has been fully validated by Health Canada, which now mandates that all drug submissions are filed electronically, according to stringent requirements.
Med-Script Associates provides R&D support by reviewing documentation generated by companies during the development phases of pharmaceuticals. The company ensures R&D activities meet the requirements of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals (ICH).
Med-Script Associates provides consulting services to guide its clients in the development of their documentation according to acceptable standards for eventual submission to the regulatory authorities. Upon request, Med-Script also prepares detailed gap analyses in order to avoid ongoing errors and to expedite the process to ensure universal regulatory acceptance.
Comprehensive regulatory services
Med-Script Associates and Med-Script Development have particular expertise and experience in the requirements of Health Canada and the Canadian Food and Drug Regulations.
Both firms collaborate extensively with companies worldwide that aim to pursue drug submissions in Canada or gain R&D advice during their early and later phases of development. The companies work closely with clients in the US, the EU, Korea and Japan.
Med-Script comprises privately owned Canadian companies that specialise in pharmaceutical regulatory affairs, R&D services and eCTD preparation.
Med-Script Associates was founded in 1972, while Med-Script Development was founded in 2014.