Licensing & Importation

Register your establishment and obtain necessary registrations for importation or manufaturing

Hassle-Free Regulatory Compliance in Drug, NHP, and Medical Device Fields!

AXSource has over 30 years of expertise in Drug Establishment (DEL), Site License (SL), Medical Device (ISO13485/MDSAP) Establishment License (MDEL) applications, maintenance, amendments, and renewals. To quickly get started, we support your regulatory work to register the products (e.g. DIN, NHP, medical device) at the same time, work on ensuring your compliance systems are inspection-ready. Our highly specialized staff takes care of modeling and establishing processes that meet your business needs. There are no canned procedures. They are simple and specific for your operations. We start with the minimum procedures needed to accomplish the initial regulatory registrations. We identify only key processes needed for validation studies.

Regulations for importing a regulated product are very complicated, time-consuming, and come with surprising costs. So you don’t want to experiment with this. Whether your product is a drug, an active pharmaceutical ingredient (API), a natural health product (NHP), or a medical device, we have staff to support all.

Let us navigate this journey for you.

Driving Regulatory Excellence for Your Products, Every Step of the Way

Simplify Regulatory Compliance With AXSource: Your Partner for Seamless Licensing and Registration!

She offers outstanding qualifications in pre-marketing government liaison with the EU, FDA & Health Canada, Notified Bodies, legal support, implementation of compliance programs including Quality Management System design, certified quality auditing, validation (specializing in software system validation), risk management/mitigation, and process improvement. Nav is a US patent holder for a Quality and compliance Solution (QCS™ software) fully integrated with Microsoft’s Dynamics D365 Finance & Operations solution.

Navneet has volunteered as a member or chair in many industry associations (CAPRA, PSG, MEDEC/MEDTEC CANADA, EFC/MIISC, PDA, ISQA & RAPS). More recently, she has been responsible for board governance for the Halton Police Service Board & Ontario Energy Board (OEB).