Aequus Pharmaceuticals has announced a positive update on the regulatory and launch advancement for the Evolve® line of preservative free dry eye products into Canada.
Medicom Healthcare, the UK manufacturer of Evolve® products, has received a positive outcome of the Audit to meet standards for the Canadian Medical Device Single Audit Program (MDSAP). The MDSAP, fully implemented by Health Canada in January 2019, establishes a new audit standard for all medical device manufacturers who distribute in Canada, including those with existing marketed products. As a result, there has been a large demand for the completion of audits and delays have been experienced across the industry. Aequus is pleased that the Medicom audit met the Canadian regulatory standards and we are excited to have this important regulatory step achieved for these new-to-the Canadian market medical devices.
As the auditing bodies prepare the formal MDSAP certificate, Canadian launch planning is fully underway. Adaptability to the current and coming circumstances as a result of the COVID-19 pandemic is being integrated into strategic business models. These include the development of an e-commerce distribution channel for product access during self-isolation, as well as establishment of strategic B2B partnerships for clinical distribution as return to work in the healthcare sector is enabled, which will bolster our existing “boots on the ground” sales infrastructure.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
“During this time, Aequus is working diligently to prepare for a new normal, by crafting innovative models that integrate existing retail structures, with more wide-reaching virtual channels,” said Anne Stevens, COO and Director of Aequus. “These models will virtually support Canadian optometry clinic retailers who have been forced to close during the pandemic, while simultaneously expanding the availability of Evolve® products to patients at launch.”
No issues with the supply chain for Evolve® products are anticipated, as Medicom continues to manufacture and distribute to 35 countries, and has been further developing and launching new products during this period.