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Starodub Services List
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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
Annex XVI products
Drug-device combination 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
(Bio)Pharmaceuticals
Non-Clinical
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 Support
Due diligence
Gap assessment
Technical Writing
Agency Interactions
Regulatory
PIP & iPSP
Regulatory Support for Small Molecules
Designation support
Support for biologicals
Small & Medium Enterprise
CTD Module 1 support
RA support (interim, temporary, long lasting)
Life Cycle Management
Orphan Drug Designation Support
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
Valentyna Starodub
Founder and Chief Executive Officer
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