Regulatory Affairs Solutions
Accurate FDA Consultants will immediately supplement your organization to provide various regulatory solutions, including various product dossiers and submissions for review and approval by the authorities such as FDA and International Regulatory Authorities.
Regulatory Submissions:Accurate FDA Consultants provides our clients guidance through the entire regulatory submission process.
Our consultants have both industry experience in preparing submissions and have an excellent track record for interfacing with the appropriate regulatory authorities and helping firms achieve their regulatory objectives.
We provide the following Regulatory Services:
Medical Devices and IVD Submissions
- 513g Request for Classification
- Pre Market Notification (510k)
- Investigational Device Exemption (IDE)
- Pre Market Approval (PMA)
Pharmaceuticals and Biologics Submissions
- Investigational New Drug (IND)
- New Drug Application (NDA)
- Biological Application License (BLA)
Combination Products Submissions
- Request for Designation (RFD)
- Drug/Device with Drug PMOA- NDA with PMA
- Device/Drug with Device PMOA- PMA with NDA
Experienced U.S. Agent- Registration and Listing
Accurate FDA Consultants continues to serve a multitude of satisfied foreign medical device and pharmacetical clients around the world, as their US Agent. We can register your establishment and list your products. We will serve as your conduit between your firm and the FDA, to schedule inspections and intercept custom disputes and issues.
Contact us today for a non-obligatory consultation and quote. Let’s discuss your needs and scope of your regulatory affair project and requirements.
- New premarket submission route: FDA’s eSTAR Program from pilot to production by Oct 1, 2023
- New Updated 2021 FDA Draft Guidance Significantly Changing Premarket Submissions Requirements for Medical Device Software
- Artificial Intelligence and Machine Learning Workflow Driving Innovative Medical Device Development
- An Overview of FDA Inspections across Drugs, Biologics and Medical Devices
- New Medical Device Pathway: Safety and Performance Based Pathway
- 2020 Over-the-Counter (OTC) Drug Monographs Reform Summary