Regulatory Affairs & Strategy

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.

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Regulatory Strategy & Advice
Pharmaceuticals, Radiopharmaceuticals, Biologics, Biosimilars & Combination Products Medical Devices and Diagnostics NHPs Dietary Supplements Cosmetics
Pre-Submission Meetings with Agencies
Canada

Health Canada

United States

Food & Drug Administration

Europe/UK

European Medicines Agency / Medicines and Healthcare products Regulatory Agency

Australia

Therapeutic Goods Administration

All Application Types
Pre-clinical & Clinical Trials Management
CTA, CTA-A IND CTA CTN, CTX ITA, IDE, HDE CTA Not applicable
Submissions/Dossiers
NDS, SNDS

CMC

ANDS

SANDS

DINS

MF

NDA

BLA

SNDA

ANDS

DMF

Original

Variations

MAA-CP

DCP, MRP

DMF

NCEs

Generics

Variations

 

PMA

510k

Class II-IV

Technical File Design Dossier

CE Marking

PLA

NPN

SLA

QAR

NDI

 

VCRP

Cosmetic Notifications

Other Services

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

To find out more about how AXSource can help you, please call us at +1 905-854-6059 or email us at info@axsource.ca