Go-To Partner for Regulatory Excellence!
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.
Our consultants have registered and licensed over 125,000 products with global regulatory agencies.
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Regulatory Strategy & Advice |
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| Pharmaceuticals, Radiopharmaceuticals, Biologics, Biosimilars & Combination Products | Medical Devices & Diagnostics | NHPs Dietary Supplements | Cosmetics | |||
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Pre-Submissions 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 |
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Pre-clinical & Clinical Trials Management |
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CTA CTA-A |
IND | CTA |
CTN CTX |
ITA IDE HDE |
Not applicable | Not applicable |
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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 |
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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 |
