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.
Regulatory Strategy & Advice |
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Pharmaceuticals, Radiopharmaceuticals, Biologics, Biosimilars & Combination Products | Medical Devices & Diagnostics | NHPs Dietary Supplements | Cosmetics | |||
Pre-Submission Meetings with Agencies |
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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 |
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CTA CTA-A |
IND | CTA | CTN CTX |
ITA IDE HDE |
CTA | Not applicable |
Submissions/Dossiers |
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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 |
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•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