Here is a sampling of the kind of projects we offer

 

Quality Systems

  • Mock FDA inspections

  • FDA-483 responses

  • 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

 

FDA TRAINING 

  • GMP TRaining

  • 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.

  • design input

  • design output

  • design verifiction

  • design validation

  • design review

  • 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