As one of the most experienced GMP Audit Companies, our committed expert regulatory affairs professionals bring extensive experience when it comes to assessing your operations. Our GMP Audit Services are comprehensive system reviews that highlight gaps in your pharmaceutical quality management system. As a responsible GMP audit company we also provide pragmatic solutions for any identified gaps. Finally, as an integral part of our GMP audit services, the experts at MCS are also available to implement solutions rapidly but effectively.
We can support your entire registration process, from initial submission preparation right through to the review process, as one of the most experienced Regulatory Affairs consulting GMP Audit companies in Canada. We routinely handle your pharmaceutical submissions with Health Canada, whether your product requires a label review, amendment, or creation of a new one.
Timely approvals, in part, require having the right team on your side that understands the issues that impact the review of new drug submissions that stay on top of current regulations that may impact the development and approval of your products, as well changes to the regulatory landscape that may challenge efforts.
Solutions and GMP Audit Services
GMP audit services are essential for the preparation and filing of the following pharmaceutical regulatory submissions. We prepare and file the following pharmaceutical regulatory submissions:
New Drug Submissions (NDS)
Our Regulatory Affairs consulting experts have experience with NDS application packets. New Drug Submissions with Health Canada for brand-name patented drugs include preparation and filing scientific information about product safety, efficacy, and quality, claimed therapeutic value, conditions for use and side effects, results of pre-clinical and clinical studies, production details, packaging and labeling information.
Abbreviated NDS (ANDS) for generic drugs
The ANDS submission involves submitting data that shows how the generic product performs when compared with the brand-name product. It must be shown to be as safe and efficacious as the brand-name product and must meet the same quality standards as an NDS; that is why when working with GMP Audit companies in Canada, we identify and correct non-conformities or deviations that could affect the product quality or safety. Submission includes scientific information, production details, packaging and labeling, and comparative bioavailability studies showing how the generic drug can deliver the same amount of medicinal ingredient at the same rate as the brand-name product.
Supplemental NDS (SNDS) for already-authorized drug products
Includes changes to dosage form or strength, formulation, manufacturing method, labeling, recommended route of administration or to expand the claims or conditions of use (indications). Our expert Regulatory Affairs consultants ensure that all modifications are thoroughly reviewed and compliant.
Drug Identification Number (DIN)
Our team prepares and submits applications for Drug Identification Number for products in Canada that do not meet the definition of a ‘new drug’. However, if the substance for use as a drug has already been available for sale over a sufficient time period and quantity to establish its safety and effectiveness.
Pharmaceutical Drugs Directorate (PDD)
The Pharmaceutical Drugs Directorate in Canada is the agency that reviews the DIN application. An acceptable label design is required to show the PDD that the product is not going to be marketed in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, efficacy, quantity, composition or safety. The comprehensive and in depth GMP Audit services offered by our firm confirm your product’s readiness for market.
