Regulatory Affairs

NAVIGATE GLOBAL REGULATORY WITH CONFIDENCE

Regulatory Approvals Annually

97%

Regulatory Inspection Outcomes

100%

Adverse Event Reporting Timeliness

Navigating Clinical Trial Regulatory Is Overwhelming

Clinical trial regulatory application is complex and constantly changing—compliance can be difficult and a costly affair, especially for international clinical trials.

Challenging global compliance with diverse guidelines
Time-consuming adaptation of documents (protocol, ICF, IB, CRF) to new submission rules
Prompt reporting needed for Safety (AEs, SAEs, AESI)
Risks include Warnings, Terminations, Fines, Convictions, Liabilities for non-compliance
Delays affect trial timelines and budgets
Added pressure from Regulatory Inspections and Audits

You Don’t Need
To Figure It Out.

Your clinical product is so valuable. Partner with an expert team committed to your regulatory success.

With over 20 years of industry experience, our experts bring a wealth of diverse expertise, a proven track record, and successful engagements spanning 40 countries.

Voices of Trust

Discover What Our Clients Have to Say About Their Experience

Don’t be overwhelmed by complexity. Our partners experienced the confidence and freedom that comes from our deep expertise

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Here’s How Axon Clinical Research Helps Your Regulatory Approval and Compliance

Proceed With Confidence

Gain in-depth regulatory insights to eliminate risks and delays

Strategic Guidance

Explore optimal regulatory pathways to achieve results.

Efficient Handling

Accurate preparation, submission, and maintenance of IND/ND.

Effective Communication

Engage agencies and KOL, resolve issues, and secure approvals.

Total Compliance

Obtain IP import permits within legal frameworks.

Comprehensive Support

Address compliance issues, reporting and stay updated on guidelines throughout trials.

CONTACT US

Do not let regulatory hurdles impede your progress! Contact our team of experts for reliable guidance and support to navigate through the ever-changing regulatory landscape.