In the Life Sciences industry, all medical products in the development stages must meet stringent global regulatory standards, and nobody understands the importance of this, better than us. With our diverse global network of experts, we can help companies successfully navigate the often complex waters of the regulatory world, and steer you through the preclinical development cycle, right through to product approval.
Our comprehensive regulatory affairs services:
If you’re looking for company driven solutions that conform to even the strictest of regulatory requirements, then Agile Scientific can help you achieve exactly that. Here are just some of the regulatory services we are proud to offer:
⦁ Regulatory Strategy
⦁ Regulatory Submission Planning
⦁ Advertising/Promotion Review and Compliance
⦁ Chemistry Manufacturing & Controls (CMC)
⦁ Product Labeling Development and Strategy
⦁ Medical Writing
⦁ Clinical Trial Authorizations, Maintenance, and Trial Support
⦁ Orphan Drug and Humanitarian Device Applications
⦁ Competitive and Regulatory Intelligence
⦁ Regulatory Authority Meeting Preparation and Facilitation
⦁ Pharmacovigilance Processes
⦁ Marketing Applications
⦁ Launch and Post-Approval Activities
Latest From Our Blog
Pharmacovigilance: Its History and Development
Throughout the twentieth century, governments and businesses were pressured to produce legalization and guidance following a series of adverse events associated with medical products and drugs, and regulatory bodies underwent an evolution to try and better protect the...
How To Develop A Regulatory Strategy For Drug Development
If you’re running a new drug development company and don’t yet have a regulatory compliance department or standard operating procedures (SOPs) in place, you’ll probably need to seek professional, third party help to help support your submission strategies and develop...
What Are the Top Emerging Trends in Health IT Today?
Many more hospitals and healthcare systems have begun to adopt health IT, particularly in light of the ongoing pandemic. Along with patients themselves, they’re becoming increasingly reliant on digital health technologies, and are using them to effectively deliver...
Contact
Phone
+1.317-644-1613
info@agilescientific.net
Address
6555 Busch Blvd, Suite 245,
Columbus, OH 43229