Quality & Regulatory Consulting Solutions for Regulated Companies

Regulatory & Market Readiness

For companies preparing to enter a new market, commercialize a regulated product, expand indications or evaluate a regulatory pathway.

We help clarify the applicable route, evidence expectations, claims, documentation gaps and decision points before resources, timelines and commercial commitments are locked in.

Quality Systems & Audit Readiness

For organizations preparing for audits, inspections, customer diligence or growth that will expose the maturity of the Quality System.

We assess governance, procedures, records, training, supplier controls, CAPA, change control and evidence trails to identify the gaps most likely to create findings, delays or remediation cost.

GxP Digital Systems, AI Evaluation, CSA & Part 11

For regulated companies, GxP software providers, and AI or Regulatory Technology companies needing senior Quality and Regulatory domain expertise.

We help define intended use, risk, validation evidence, data integrity, audit trails, electronic records and signatures, supplier responsibilities and defensible computerized-system strategy. For AI-enabled products, support can include benchmark design, output evaluation, rubrics, acceptance criteria, hallucination and unsupported-inference testing, human oversight, traceability and GxP AI governance.

Remediation, CAPA & Investigation Effectiveness

For organizations dealing with recurring deviations, ineffective CAPAs, audit findings, remediation programs or weak investigation quality.

We focus on root-cause logic, systemic risk, evidence quality, effectiveness checks and governance so remediation closes the real problem rather than only the paperwork.

Fractional Quality & Regulatory Advisory

For early-stage or scaling organizations that need senior Quality and Regulatory judgment on an ongoing basis without adding permanent full-time headcount.

Support can include prioritization, governance, review of critical decisions, supplier or system oversight, readiness planning and direct implementation support where appropriate.

Product & Marketplace Compliance

For brands, manufacturers and sellers operating in categories where labeling, claims, safety, import requirements and marketplace rules can create regulatory or commercial exposure.

We support cosmetics and MoCRA, EU cosmetics, supplements, label and claims review, FTC substantiation risk, Amazon compliance, FSVP, supplier documentation and launch-readiness decisions.