Who needs a regulatory strategy? Why is it necessary?
There are a lot of questions on how to successfully launch new therapeutic products on the global market.
Developing the best regulatory strategy is absolutely critical to expediting regulatory approval, off-setting any imminent risks (i.e. from competitors) and avoiding pitfalls from changing regulations during the product development lifecycle.
AXSource consultants may look at any of the following to develop your strategy:
It’s easy to see how regulatory strategy encompasses a wide range of activities and disciplines. Having regulatory & clinical experts involved in the process from the beginning ensures a strategy is in place which aligns both marketing & regulatory activities.
AXSource consultants will provide you with a documented regulatory strategy which defines a path for expeditious approval (including any contingencies), aligns with regulatory agencies, and can be easily communicated to all stakeholders.
Without a strategically planned approach, it becomes near impossible to mitigate risk. In such cases, companies will likely experience unforeseen risks, issues causing unexpected delays, increased costs, a waste of resources and missed requirements.
Let AXSource develop the best regulatory strategy for you, so that you are first to market your products!
Regulatory Affairs Services
AxSource provides professional consulting and regulatory affairs services for pharmaceuticals, biologics, active pharmaceutical ingredients (APIs), over-the-counter (OTC), Natural Health Products (NHPs), cosmetics and medical devices.
Our team of experts can provide on-site, virtual and strategic support for your products in major jurisdictions such as Canada, the United States, UK, Australia & the European Union.
Download the below Chart
|Regulatory Strategy & Advice|
|Pharmaceuticals, Radiopharmaceuticals, Biologics, Biosimilars & Combination Products||Medical Devices and Diagnostics||NHPs Dietary Supplements||Cosmetics|
|Pre-Submission Meetings with Agencies|
|Canada||United States||Europe/UK||Australia||All Application Types|
|Pre-clinical & Clinical Trials Management|
|CTA, CTA-A||IND||CTA||CTN, CTX||ITA, IDE, HDE||CTA||Not applicable|
Technical File Design Dossier
Product Quality Assurance Coordination during Registration/Licensing
Product Promotional & Labeling Reviews (LA/SA)
Agency Query Management
Direct, Online & Publishing Services (eCTD, NeeS, Conversions, Paper)
Establishment Registrations, Licenses & Listing
Annual Product/Facility Renewal Services
Application Fee Management