How we do it

A Proven Process for Startups, Scale-Ups, and Cleanups:

  • We start with a readiness assessment to pinpoint gaps, risks, and opportunities. Whether you’re launching or remediating, we build a tailored roadmap so you know exactly what to expect.

  • From facility layout to equipment validation, we plan every step to meet 503A, 503B, and GMP requirements — keeping compliance at the core.

  • We oversee implementation, training, and inspection readiness. The goal isn’t just to pass — it’s to pass the first time and position your operation for long-term success.

  • After launch, we stay with you to monitor performance, maintain compliance, and solve issues before they become problems.

Want results like these?

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Facility Design, Feasibility, & Expansion 

30+ Facilities Designed with Compliance & Throughput in Mind

Over a span of 3 years, we developed vision documents and layout strategies for 30+ clients—maximizing throughput and compliance with the smallest cleanroom footprint.

USP <800> Feasibility for Clinical Trial Compounding Pharmacy

We assessed options to expand into HD sterile compounding, evaluated four buildout paths, and gave the client a strategic roadmap.

Global Pharma Reassesses 503B Entry After Full Due Diligence

We delivered risk research, a sample layout, revenue modeling, and site readiness review. They chose not to pursue—saving millions.

Big Pharma Evaluates 503B Expansion Strategy

We provided gap assessments, SOP reviews, and a roadmap to 503B readiness. The client ultimately pivoted away from the plan, but retained all deliverables for future use.

Design smarter. Build faster. Stay compliant.

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 Audit Readiness & Regulatory Defense

503A in California Passes Inspection & Closes M&A Deal

We helped a high-risk, sterile nonsterile-to-sterile pharmacy address CA Board gaps before inspection. They passed with no findings and completed a successful acquisition.

503A Secures NABP Accreditation After Deficiencies

We performed a full gap analysis and helped the client submit a successful response. Accreditation was granted without reinspection.

503A Pharmacy BUD Dispute Resolved Without Penalty

A Board inspector challenged their BUD. We found a lab error, got the study redone, and avoided enforcement.

503B Opens With Zero 483s—An Exceptionally Rare Result

Our pre-inspection audit caught critical gaps. The client remediated, and FDA found no observations.

Comprehensive 503A Gap Analyses Across the Country

From hospital Category 1 to high-risk sterile-to-nonsterile Category 3, we help 503As prepare for inspections with a proven four-phase methodology.

Avoid observations—get audit-ready support

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 Expert Witness & Legal Support

Expert Testimony in High-Stakes Regulatory Cases

From BUD defense to essential copy and compounding allegations, our insight helped clients win or settle major Board and legal actions.

Need a credible expert?

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 Regulatory Strategy & Drug Eligibility

WHO-Recognized Drug? Not Legal to Compound in U.S.

We performed a feasibility study for a global company seeking to compound a lifesaving API. Our research showed no legal pathway—and saved the client from regulatory exposure.

Ready to get started?

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 CGMP Validation Services

CIP Validation for High-Throughput Nonsterile Line

We validated a complex clean-in-place process for a proprietary nonsterile automation system—designing sampling strategies, acceptance limits, and a custom protocol that passed on the first try.

Temperature Mapping: Warehouse & Controlled Units

We temperature-mapped the client’s full warehouse and all refrigerators, freezers, and incubators—resolving excursion risks and passing FDA inspection with zero observations.

IQ/OQ/PQ for Depyrogenation Oven & Autoclave

We qualified new sterilization equipment with full cycle development, BI testing, and audit-ready documentation—ensuring FDA compliance from day one.

Computer System Validation for Electronic QMS

We led a full CSV project for a 503B’s transition to electronic batch records and deviation tracking—ensuring 21 CFR Part 11 compliance and seamless inspection readiness.

Want help validating your systems?

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