Here is a sampling of the kind of projects we offer
Mock FDA inspections
FDA Warning Letter responses
Solving FDA problems
FDA REGULATORY SUBMISSIONS
New Product Requirements
Regulatory Advisory Letter to detail FDA requirements
510(k) Premarket Notification
IDE - Investigational DeviceExemption
De Novo application
Premarket Approval Application
regulatory Submissions training
internal auditor training
fda labeling and advertising training
TRAIN THE TRAINERS.
DESIGN CONTROL (21 CFR PART 820.30)
Assistance in establishing and maintaining a state of the art design control procedures which assures development of clinically significant features.
mock FDA design control audit.
CLINICAL STUDY DESIGN AND MANAGEMENT
How to conduct a an efficient effective clinical trial that meets FDA requirements.
Establishing clinical endpoints
Creating clinical protocols.
Informed Consent Documents
Obtaining IRB approval
Managing clinical trials
FDA IDE approvals
Mock FDA BIMO Audits
FDA MEETINGS (PRE SUBMISSION)
To obtain FDA concurrence with the regulatory and/or clinical plans
CONTACT FDA AND ARRANGE MEETING
PREPARE AND SUBMIT THE MEETING REQUEST
BE THE PRIMARY FDA CONTACT FOR THE MEETING
CONDUCT MEETING (PHONE OR ON SITE)
PREPARE MEETING MINUTES FOR FDA