Regulatory, quality, and clinical consulting for medical device + pharma teams.
Support across regulatory strategy, submissions, clinical, and quality systems for teams that need audit-ready documentation and clear execution.
What they help with.
Preferred Regulatory Consulting provides expert consulting across these key areas.
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
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
How teams use this together.
Typical workflows that combine Outwrit with Preferred Regulatory Consulting's expertise.
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.
Santhi Analytis, PhD
Advisor. Regulatory affairs, clinical research, and quality management.
Andy Clark, PhD
Advisor. Regulatory affairs, clinical research, and quality management.
Revati Shreeniwas, MD
Advisor. Regulatory affairs, clinical research, and quality management.
Articles and publications.
Regulatory
Principles For Medical Device Security
2016: AAMI TIR57:2016 Principles For Medical Device Security - Risk Management
Quality Management System
2015: AAMI TIR48:2015 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
Labs Prepare for Eventuality of FDA Oversight
2015: LDT Labs Prepare for Eventuality of FDA Oversight
Environmental monitoring for terminally sterilized healthcare products
2014: AAMI TIR52:2014 Environmental monitoring for terminally sterilized healthcare products
Pulmonology
Inhaled Medicines: Past, Present, and Future
2022: Inhaled Medicines: Past, Present, and Future
Pharmacokinetics and safety of paclitaxel delivery into porcine airway walls by a new endobronchial drug delivery catheter
2018: Pharmacokinetics and safety of paclitaxel delivery into porcine airway walls by a new endobronchial drug delivery catheter
Pharmacokinetics of Paclitaxel Delivery for the Airway by a New Endobronchial Drug Delivery Catheter
2013: Pharmacokinetics of Paclitaxel Delivery for the Airway by a New Endobronchial Drug Delivery Catheter: Experimental Study
Macro and microscopic evaluation of paclitaxel delivery in the airway with a novel endobronchial injectable drug delivery catheter
2013: Macro and microscopic evaluation of paclitaxel delivery in the airway with a novel endobronchial injectable drug delivery catheter
Cardiology
Novel Toxicology Program
2020: Novel Toxicology Program to Support the Development of Inhaled VentaProst
Prediction of troponin elevation by means of intracoronary electrocardiogram during percutaneous coronary intervention of coronary bifurcation lesions
2016: Prediction of troponin elevation by means of intracoronary electrocardiogram during percutaneous coronary intervention of coronary bifurcation lesions (COSIBRIA & Co Study)
Microbiology
Dynamics and Control of Biofilms of the Oligotrophic Bacterium
2004: Dynamics and Control of Biofilms of the Oligotrophic Bacterium Caulobacter crescentus
Biotin in microbes
2003: Biotin in microbes, the genes involved in its biosynthesis, its biochemical role and perspectives for biotechnological production
Functional Analysis of Sinorhizobium meliloti Genes Involved in Biotin Synthesis and Transport
2002: Functional Analysis of Sinorhizobium meliloti Genes Involved in Biotin Synthesis and Transport
Direct Cloning from Enrichment Cultures
2001: Direct Cloning from Enrichment Cultures, a Reliable Strategy for Isolation of Complete Operons and Genes from Microbial Consortia
About Preferred Regulatory Consulting.
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.
Ready to work with Preferred Regulatory Consulting?
Combine evidence discovery with expert consulting for audit-ready compliance.
Partner services are delivered by Preferred Regulatory Consulting. AI Gap Analysis provides software tooling for evidence discovery. Always apply professional judgment.