Site Selection/Qualification Visits (SQV)
Site Initiation Visits (SIV)
Interim Monitoring Visits (IMV)
Source Data Verification (SDV)
Close-Out Visits (COV)
Study Documentation Control
Adverse Event (AE) Reporting
Study design, planning & optimization
Site Nomination
Clinical Investigation Plan (CIP)
Investigator’s Brochure (IB)
Case Report Forms (CRFs)
Informed Consent Form (ICF)
Preparation of Monitoring Plan
Ethics Committee Submissions
Regulatory (Competent Authority) Submissions
EU
CE Mark Strategic Planning
Preparation of Technical Documentation
MDD to MDR Transition
IVDD to IVDR Transition
MDR/IVDR GSPR Overview
Product Classification
Clinical Evaluation
Performance Evaluation
Derma filler (injectable implants) compliance with EU MDR 2017/745
PMCF/HCP Surveys
Notified Body Contact
Person Responsible for Regulatory Compliance (PPRC)
USA
FDA 510(K)
EUA
Our extensive experience and therapeutic knowledge are valuable when preparing plans and reports essential for an optimal regulatory strategy. Our services are compliant with ISO14155:2020, MDR 2017/745, and MEDDEV 2.7/1 Rev 4 guidelines.
More about medical writing
Clinical Investigational Plan (CIP)
Clinical Performance Study Plan (CPSP)
Investigator Brochure (IB)
Clinical Study Report (CSR)
Annual Safety Reports (APR)
Clinical Evaluation Plan (CEP) and Report (CER)
Performance Evaluation Plan (PEP) Report (PER)
Summary of Safety and Clinical Performance
Post Market Clinical Follow Up (PMCF) Plan
PMCF Evaluation Report