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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Regulatory 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 |
Drive Regulatory Excellence Across Pharmaceuticals, Biologics, and Beyond – Partner With AXSource for Proven Success!
FAQs on Regulatory Submissions
1. What is the regulatory submission process?
The regulatory submission process involves preparing and submitting documentation to regulatory authorities to obtain approval for products such as pharmaceuticals, medical devices, and biologics. This process ensures that products meet safety, efficacy, and quality standards.
2. What types of documents are included in regulatory submissions?
Regulatory submissions typically include:
- Clinical trial data
- Manufacturing information
- Quality control data
- Non-clinical study reports
- Labeling and packaging information
- Risk management plans
3. What is regulatory submission software?
Regulatory submission software is a tool designed to streamline the preparation, management, and submission of regulatory documents. It helps ensure compliance with regulatory requirements and improves the efficiency of the submission process.
4. What are the benefits of using regulatory submission software?
Benefits include:
- Improved Efficiency: Automates document preparation and submission processes.
- Compliance: Ensures submissions meet regulatory standards and guidelines.
- Document Management: Facilitates organization, tracking, and version control of submission documents.
- Collaboration: Enables teams to work together seamlessly on submission projects.
5. How does regulatory submission management work?
Regulatory submission management involves coordinating the preparation, review, and submission of regulatory documents. This includes setting timelines, assigning tasks, ensuring document quality, and tracking submission status.
6. What regulatory submission support services are available?
Support services for regulatory submissions can include:
- Consulting: Expert advice on regulatory strategy and submission requirements.
- Document Preparation: Assistance with writing, reviewing, and formatting submission documents.
- Submission Management: Coordination of the entire submission process.
- Regulatory Intelligence: Keeping up-to-date with regulatory changes and requirements.
7. What are common challenges in the regulatory submission process?
Common challenges include:
- Keeping up with changing regulations
- Ensuring document accuracy and completeness
- Managing timelines and deadlines
- Coordinating between different teams and departments
8. How can business ensure successful regulatory submissions?
Businesses can ensure successful regulatory submissions by:
- Staying informed about regulatory requirements
- Using regulatory submission software to streamline processes
- Engaging experienced regulatory consultants
- Implementing robust document management systems
