Regulatory Affairs Services

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 & Diagnostics NHPs Dietary Supplements Cosmetics

Pre-Submission Meetings with Agencies

Canada:
Health Canada
United States:
Food & Drug Administration (FDA)
Europe/UK:
European Medicines Agency (EMA) / Medicines and Healthcare Products Regulatory Agency (MHRA)
Australia:
Therapeutic Goods Administration
All Application Types In exceptional cases In exceptional cases

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
510(k)
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.com