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INDUSTRY FOCUS
IVDs
Medical Devices
Gene and Cell Therapies
Biopharma
Pharmaceuticals
SERVICES
Technology
Clinical
Regulatory
Marketing
Post-Market
PROJECTS
EUA Application
Medical Device 510K
Clinical study
OTC Drug
Facility Registration and Listing
FDA US Agent
Food and Dietary Supplements
CGMP
Marketing
Setup and Operation of US Based Sale Office
RESOURCES
All Resources
ABOUT
Our Company
Team
Contact Us
Get In Touch
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Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.
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Body of Knowledge (BOK)
Determining the Right Regulatory Pathway for your Drug
A fundamental question in any drug development program is which regulatory pathway to pursue...
510k Submissions for Sterile Devices
A lot of work goes into a 510k submission for a medical device. Companies that submit a 510k for a product have to...
The FDA, CBD, and OTC Drugs
When making a new product, whether that product is a drug, a medical device, or a combination product, understanding the regulations...
Intended Use Validation
Medical Device Manufacturers in the United States have to comply with intended use validation (IUV) requirements.Intended use is...
5 Reasons Why Internal Auditing is Important
An internal audit program is vital for proper monitoring and assurance of products. It is also essential to verify that individual processes...
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