When you partner with RadPharm, you can rest assured knowing your clinical trial is in expert hands and therefore in compliance with strict regulatory standards, from charter development through agency submission.
As the most experienced imaging core lab in the industry, RadPharm leverages our medical and regulatory leadership to ensure the success of your drug and medical device development program. Our regulatory experts work closely with you and regulatory bodies to drive efficiencies and ensure both protocol and regulatory compliance.
We offer deep familiarity working with world regulatory agencies and have played a key role in defining imaging charters standards for FDA review. Further, our clinical data submission processes mirror FDA guidelines, ensuring your studies success.
RadPharm is committed to providing quality service, accurate data and regulatory know-how. Having successfully submitted to the FDA, clinical data for numerous approved compounds in varied therapeutic areas, RadPharm provides you with unequalled expertise to effectively guide you through the regulatory process.
RadPharm offers:
- Experienced regulatory guidance, including in person consultation
- Proven project planning
- Image repository and documentation database design and delivery
Trust your next regulatory submission to the experts. Contact us today at 609-936-2600 or via contact us.
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