7749 Normandy Blvd.
Jacksonville, FL 32221
Services/Audit Ready Compliance Documentation
What Our Clients Think About Us
Years of audit experience coupled with scientific training and a thorough knowledge of regulatory and quality system requirements enable us to deliver simple clearly written audit ready documents.
Not sure if your design and development documents are audit ready? Are your quality system documents clear? Are they compliant?
We specialize in writing documents that clearly communicate intended content to auditors, health authorities and subject matter experts minimizing redundancies and inconsistencies between documents and improving content quality. Our expertise includes documents which demonstrate compliance to quality systems requirements and those that support your regulatory submissions.
Categories include Design and Development, Post Market Changes, Design Control Document Deliverables, Design and Process Validation Deliverables, Design History Files, Quality System Procedures, 510(k) clearances, PMA’s, NDA’s, aNDA’s and more.
Contact us today to see how your documents can be clearly written, audit ready and meet both quality system and business requirements.
MD & PC Mission Statement:
Delivering compliant, audit ready quality system documents and solutions that support new product introductions, regulatory submissions and global quality system requirements for the medical device and pharmaceutical industries