Regulatory Services

SRX Health Solutions is Canada’s premier provider for patient support programs. SRX has industry leading technology that helps support full-service patient support programs to help meet all of your patient and physician needs, as well as meet the ever-changing needs of the Canadian healthcare landscape.

All of our programs are individually developed to ensure that you are implementing the best possible program which delivers optimal health outcomes. Our programs are structured in a way that drives accountability, supports best in class reimbursement practices, and is consistently available to those who are part of your program. We understand that the Canadian healthcare system can be difficult to navigate for patients, and at SRX we pride ourselves on ensuring that patients can receive their medication as quickly as possible.

Our PSP team provides:

Identification of applicable regulatory requirements, market and customer drivers

Development of regulatory strategy and submissions to Health Canada

Compliance Assurance Process implementation

Direct access to on-call regulatory/consulting support

Regulatory and research Q&A style support

Product classification and label development

Advertisement review in conjunction with the Pharmaceutical Advertising Advisory Board

Monthly reports on health requirements, including the impact on patients

Real-time Information Change Notices (INCs) on important changes to health requirements

Substantiating waiver requests and read-across arguments

Clinical trial submissions

Providing product safety and efficacy evaluations along with developing Risk Management Plans

Conducting human health and environmental risk assessments and evaluations of unique chemical hazards

Third-party technical liaison

Any other related regulatory services required for your products

With our team you can be sure that we will:

Manage your compliance and regulatory strategy and risks

Develop and sustain a competitive advantage for your products

Protect your brand strategy

Minimize business impacts such as loss of sales, product recall, and obsolete inventory