Hellerstein Consulting
Consulting firm providing regulatory, quality systems, and product development support to biotech, pharmaceutical, diagnostics, and research organizations. Services emphasize design and implementation of quality systems, preparation and electronic submission of regulatory filings, representation before regulatory authorities, and ancillary support for product development projects.
Industries
Nr. of Employees
small (1-50)
Hellerstein Consulting
Atlanta, Georgia, United States, North America
Services
Design and implementation of quality systems, drafting and review of quality documentation, contract quality services, and audits.
End-to-end regulatory support including drafting and assembly of filings, electronic submissions, expert advice, and representation before regulatory bodies.
Ancillary services to support product and service development projects in biotech and pharma, adaptable to different development phases.
Design and implementation of quality systems, drafting and review of quality documentation, contract quality services, and audits.
End-to-end regulatory support including drafting and assembly of filings, electronic submissions, expert advice, and representation before regulatory bodies.
Ancillary services to support product and service development projects in biotech and pharma, adaptable to different development phases.
Expertise Areas
- Regulatory compliance and submissions
- Quality systems design and auditing
- Product development support for biotech and diagnostics
- Regulatory strategy and agency representation
Key Technologies
- Electronic regulatory submissions
- Quality management systems (QMS)
- Regulatory dossier compilation
- Product development project support methodologies