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Starodub Services List
Explore the tree view of our services extensive list
Tree view of services
Medical Devices
Quality Assurance
QMS Consulting
Mock Audit for ISO 13485
Risk Management for Medical Devices According to ISO 14971
Regulatory
Implantable medical devices
Drug-device combination products
Annex XVI products
Medical devices that incorporate ancillary substances
Regulatory Affairs Training
Gap Analysis for MDR 2017/745
Product Qualification
Medical Device Technical Documentation
Medical Device Classification
Clinical
Clinical Evaluation of Medical Devices
Literature search for medical devices
Post-market Clinical Follow-Up
Medical Device Clinical Investigations under ISO 14155
Standards Compliance
Biological Safety and Biocompatibility of Medical Devices
Quality, Operations & Improvement
Compliance & Quality
(Interim) QA management and project leadership
Audit readiness & inspection support
CAPA and deviation management
Change Control and Project Management
Data Integrity assessments
Gap assessments of quality processes
GMP and GDP compliance
QP services & batch release
Operational Performance Support
(Interim) operations management and leadership
Bottleneck analysis
Escalation handling and process structure
KPI design and performance dashboards
Practical process support
Value Stream Mapping (VSM)
Training & Awareness
Coaching and development of team leaders
Culture interventions aimed at compliance
Data Integrity workshops (customized)
GMP training for operators and supervisors
Root Cause and CAPA
Training-on-the-job and implementation support
Lean Improvement Programs
Department-specific Lean initiatives
Full Lean transformation programs
Lean support for Quality & Operations
Value Stream Mapping and waste reduction
(Bio)Pharmaceuticals
Non-Clinical
Non-clinical/Technical Writing
CRO selection and management
Toxicological Risk Assessment
Due diligence
Gap assessment
Agency Interactions
Drug development strategy and program
Toxicology study Design
Clinical
Due diligence
Gap assessment
Agency Interactions
CMC
Drug Master Files (ASMF, CEP) writing and gap assessment
CMC Drug Development Regulatory Consulting Service
Due diligence
Gap assessment
Technical Writing
Agency Interactions
Regulatory
Small Molecules
PIP & iPSP
Designation support
Advanced Therapy Medicinal Product (ATMP)
Biologicals/Biotech
Small & Medium Enterprise
CTD Module 1 support
RA support (interim, temporary, long lasting)
Life Cycle Management
Orphan Drug Designation
Agency Interactions
Regulatory Guidance Check
Due Diligence
Gap Assessments
Agency Interactions
Regulatory Operations
eCTD (electronic Common Technical Document)
Document Management System (DMS) Support
Submission preparation support
Regulatory Information Management (RIM)
Electronic Submission Support
Patrick Vronen
Management team member - Senior RA Consultant
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