Regulatory
- Regulatory intelligence and due diligence
- Worldwide regulatory strategy and submission planning
- Device pathways: pre-subs, IDE, 510(k), PMA, HDE, de novo
- Pharma pathways: pre-IND, IND, orphan-drug requests
Back to partners
Preferred Regulatory Consulting
Regulatory, quality, and clinical consulting for medical device + pharma teams.
Website: preferredregulatoryconsulting.com
What they help with
Quality
- QMS and GMP compliance
- SOP authoring and document control
- Internal and supplier audit support
- Risk analysis, mitigation, and UDI support
Clinical
- GCP-aligned clinical documentation
- Protocol/report and IRB/EC package support
- Clinical study management support
Typical use cases with AI Gap Analysis
- Run a fast first-pass gap analysis, then apply consultant judgment to determine what counts as defensible evidence.
- Turn missing or partial findings into a prioritized remediation plan tied to SOP and document updates.
- Prepare for audits and submissions with a cleaner evidence trail and clearer documentation deltas.
- Standardize recurring review cycles across regulatory, quality, and clinical teams.
Meet the experts
Plamena Entcheva-Dimitrov
Founder.
About
Preferred Regulatory Consulting supports medical device and pharma teams across regulatory strategy, clinical execution, and quality operations.
Public company profiles describe the firm as founded in 2011, headquartered in Eagle, Idaho, with specialties including submissions, clinical study work, CER support, and quality systems/audits.
Their service model emphasizes practical execution: submission planning, agency communication support, GCP-aligned clinical documentation, and operational quality controls.
Expertise highlights
- Regulatory intelligence, due diligence, and agency communications.
- Worldwide regulatory strategy and submission planning/management.
- Device submissions including pre-subs, IDE, 510(k), PMA, HDE, de novo, and technical files/design dossiers.
- Pharma pathways including pre-IND, IND, and orphan-drug designation requests.
- GCP-focused clinical support: protocols, reports, IRB/EC submissions, and literature packages.
- QMS/GMP compliance programs, audits, document control, UDI, and risk management.
Contact
Email: info@preferredregulatoryconsulting.com
Phone: 650-533-2253
Disclaimer
Partner services are delivered by Preferred Regulatory Consulting. AI Gap Analysis provides software tooling for evidence discovery. Always apply professional judgment.