We specialize in the regulatory writing niche of medical writing. Whether it is preparing part or the entire document, we are here to support your needs.

I. EU MDR and more...for Class I (s,r,m), Class II (a,b), Class III

• EU MDR submission support

• Clinical evaluation plans and reports

• Systematic literature review (inclusive of appraisal criteria, inclusion/exclusion criteria, data extraction for easy analyzing)

• Post-market clinical follow-up (PMCF) plans and reports

• Summary of Safety and Clinical Performance (SSCPs) for both non-implantable and implantable

• Inputs to Periodic safety update reports (PSURs)

• Periodic updates under EU MDD as products transition to EU MDR

II. EU IVDR and more...for Class A, B, C, D

• EU IVDR submission support

• Performance evaluation plans and reports

• Scientific validity, analytical performance and/or clinical performance reports that serve as an input to the PER

• Systematic literature review (inclusive of appraisal criteria, inclusion/exclusion criteria, data extraction for easy analyzing)

• Post-market performance follow-up (PMPF) plans and reports

• Periodic updates under EU IVDD as products transition to EU IVDR

III. Clinical Trial Documents

• Protocol development

• Clinical study plans and reports

• Informed consent

• Investigator brochure

• Manuscript and publication support

IV. Internal Quality Processes

• Work instruction (WI) and standard operating procedure (SOP) development

• Template development for all above documents

We have experience with the entire clinical trial process and are here to assist you with your clinical trial needs from strategy to market.

I. Site Selection

• Site feasibility assessment

II. Study Start-Up

• Informed consent review

• Contract and budget negotiations

• Clinicaltrial.gov registration

• IRB Submission

III. Monitoring

• Remote and on-site monitoring (SQV, SIV, IMV, COV)

• Monitoring plans and reports

IV. Trial Master File

• Site files and documentation organization