From FDA Form 483, to Warning Letters, to Consent Decrees, RCM helps regulated customers ranging from smaller device manufacturers to Fortune 100 Pharmaceutical companies address regulatory inspection observations.

    Our services include:

    • Analysis of the provided observations and identification of the remediation strategy
    • Response to FDA observations based on FDA guidance and good industry practices
    • Implementation of the identified remediation
    • Collecting and submitting the evidence of the observation closure
    • Assessment of the overall organizational compliance and quality state
    • Improvement and prevention of future FDA observations
    • Etc. 

    Start With a Phone Call

    Speak with one of our SME's. The result may be: 

    • Advice 
    • Free Consultation 
    • Gaining a trusted advisor and networking partner

    Our offerings are as flexible as our clients’ needs and range from staff augmentation to
    scalable turn-key solutions and we look forward to hearing from you.