Regulatory Affairs

Your organization is called upon each day to present critical insight and guidance specific to your products’ regulatory requirements for submission, approval, and continued marketing.

Regulatory Affairs Services

Want to be sure you are achieving the best industry practices and standards?

Resources, experience and expertise are key to effective Regulatory Affairs Management.

At Protocol Link, our Regulatory Affairs experts meet with you to define specific strategies and accomplish your regulatory objectives. We work with your core team as your regulatory partner and ensure deadlines are always achieved. Our staff understands the negotiation and communication requirements necessary for success and works with you to interface with the FDA and other regulatory bodies to ensure effective outcomes.

Regulatory responsibilities continue well beyond submission approval and Protocol Link is prepared to assist with post approval support. Our regulatory, compliance, scientific, legal, and technical consultants are experienced in product launch, eCTD requirements, FDA Electronic Submissions Gateway (ESG) requirements, DDMAC requirements, Adverse Drug Report preparation, Annual Reporting requirements, and recall management.

Protocol Link’s expert staff is prepared to supplement your team and serve as your Regulatory Affairs partner in preparing, compiling, and submitting original eCTD XML applications as well as maintaining approved products throughout the FDA regulatory lifecycle. We’re proud of our experience in dealing with sensitive regulatory matters and our ability to appropriately comprehend the measured compliance scope of each assignment.

Our Regulatory Affairs services include...

Annual Reports

CMC Development

Device Master Records (DMRs)

Drug Master Files (DMFs)

eCTD Lifecycle Management

e-Publishing via FDA ESG

FDA Center and District Liaison

Field Alert Reporting

Product Recall Management

Regulatory Affairs Management

Regulatory Submissions

US-FDA Registered Agent