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