Our Services
Services Built for Agility, Compliance, and Confidence
From building quality systems to navigating FDA inspections, we deliver senior-level expertise tailored to your stage and needs.
Build & Optimization
Quality Management Systems (QMS)
Design, implement, and mature compliant quality systems built to scale with your growth.
- SOPs, policies, and procedures aligned to FDA expectations
- Document control and training systems
- Phase-appropriate eQMS system selection and structure
Process
A Clear Engagement Process
Step 01
Discovery Call
We learn about your product, stage, regulatory environment, and key risk areas.
Step 02
Assessment
Gap analysis and a prioritized roadmap that maps exactly where to focus first.
Step 03
Execution
Systems, documentation, training, and remediation—delivered with senior-level oversight.
Step 04
Sustain & Scale
Ongoing support, audit readiness reviews, and scalable processes for long-term compliance.
Designed for early-stage teams that need guidance without adding full-time overhead.
Prepare with Confidence
FDA Compliance & Inspection Readiness
Mock inspections, gap assessments, and audit remediation to ensure you’re always inspection-ready.
- Complete readiness for FDA and third-party audits
- Remediated findings with sustainable corrective actions
- Confident leadership team during inspections
Process
A Clear, Executive-Led Engagement Process
Step 01
Discovery Call
We learn about your product, stage, regulatory environment, and key risk areas.
Step 02
Assessment
Gap analysis and a prioritized roadmap that maps exactly where to focus first.
Step 03
Execution
Systems, documentation, training, and remediation—delivered with senior-level oversight.
Step 04
Sustain & Scale
Ongoing support, audit readiness reviews, and scalable processes for long-term compliance.
Designed for early-stage teams that need guidance without adding full-time overhead.
Navigate Pathways
Regulatory Strategy & Submission Support
Clear timelines, smart pathways, and fewer surprises—from strategy through submission.
- Clear regulatory pathway and timeline
- Submission-ready documentation
- Reduced risk of regulatory delays
Process
A Clear, Executive-Led
Engagement Process
Step 01
Discovery Call
We learn about your product, stage, regulatory environment, and key risk areas.
Step 02
Assessment
Gap analysis and a prioritized roadmap that maps exactly where to focus first.
Step 03
Execution
Systems, documentation, training, and remediation—delivered with senior-level oversight.
Step 04
Sustain & Scale
Ongoing support, audit readiness reviews, and scalable processes for long-term compliance.
Designed for early-stage teams that need guidance without adding full-time overhead.
What's Included
Key Deliverables
We don’t just advise; we deliver tangible assets that strengthen your quality systems immediately.
Pathway Assessment
Determine the optimal route to market (510(k), PMA, De Novo).
Document Preparation
Authoring and compiling submission-ready technical files.
Global Strategy
Roadmaps for market entry into EU (MDR/IVDR), Canada, and more.
Submission Planning
Comprehensive project management for regulatory filings.
Agency Meeting Support
Preparation and representation for Pre-Sub/Q-Sub meetings.
Post-Market Compliance
Strategies for complaint handling, MDRs, and recalls.
Outcome
Clear regulatory pathway and timeline
Structured Corrective Action
Remediation & Risk Management
Resolve CAPAs, deviations, and audit findings with sustainable corrective action programs.
- Closed CAPAs with verified effectiveness
- Risk-based approach to deviation management
- Regulatory-ready remediation documentation
Process
A Clear, Executive-Led
Engagement Process
Step 01
Discovery Call
We learn about your product, stage, regulatory environment, and key risk areas.
Step 02
Assessment
Gap analysis and a prioritized roadmap that maps exactly where to focus first.
Step 03
Execution
Systems, documentation, training, and remediation—delivered with senior-level oversight.
Step 04
Sustain & Scale
Ongoing support, audit readiness reviews, and scalable processes for long-term compliance.
Designed for early-stage teams that need guidance without adding full-time overhead.
What's Included
Key Deliverables
We don’t just advise; we deliver tangible assets that strengthen your quality systems immediately.
CAPA Management
End-to-end handling of corrective and preventive actions.
Risk Assessment
ISO 14971-compliant risk management files and hazard analysis.
Effectiveness Checks
Verification that implemented actions truly resolved the issue.
Deviation Investigation
Thorough analysis of non-conformances and process deviations.
Root Cause Analysis
Advanced techniques (5 Whys, Fishbone) to find true causes.
Trend Analysis
Data-driven monitoring to detect emerging quality signals.
Outcome
Closed CAPAs with verified effectiveness
Supply Chain Confidence
Vendor Qualification & Supplier Quality
Evaluate, qualify, and manage suppliers to reduce risk across your supply chain.
- Qualified vendor list with risk ratings
- Supplier audit programs and scorecards
- Reduced supply chain compliance risk
Process
A Clear, Executive-Led
Engagement Process
Step 01
Discovery Call
We learn about your product, stage, regulatory environment, and key risk areas.
Step 02
Assessment
Gap analysis and a prioritized roadmap that maps exactly where to focus first.
Step 03
Execution
Systems, documentation, training, and remediation—delivered with senior-level oversight.
Step 04
Sustain & Scale
Ongoing support, audit readiness reviews, and scalable processes for long-term compliance.
Designed for early-stage teams that need guidance without adding full-time overhead.
What's Included
Key Deliverables
We don’t just advise; we deliver tangible assets that strengthen your quality systems immediately.
Vendor Audits
On-site and remote assessments of supplier capabilities.
Supplier Scorecards
Performance metrics to monitor critical vendor quality.
Risk Assessments
Evaluating supply chain risks and continuity plans.
Qualification Programs
Risk-based workflows for approving new suppliers.
Quality Agreements
Drafting and negotiating quality responsibilities with partners.
Ongoing Monitoring
Periodic review of supplier performance and compliance.
Outcome
Qualified vendor list with risk ratings
Why Choose Us
The APQR Difference
| Feature | AP Quality | Generic Firms |
|---|---|---|
| Senior-Level Expertise | ✔ | ✖ |
| FDA-Specific Focus | ✔ | ✖ |
| Hands-On Execution | ✔ | ✖ |
| Scalable Systems | ✔ | ✖ |
| Fast Engagement Start | ✔ | ✖ |
| Industry-Specific Knowledge | ✔ | ✖ |
| Feature | APQR Consulting | Generic Firms |
|---|---|---|
| Senior-Level Expertise | ✔ | ✖ |
| FDA-Specific Focus | ✔ | ✖ |
| Hands-On Execution | ✔ | ✖ |
| Scalable Systems | ✔ | ✖ |
| Fast Engagement Start | ✔ | ✖ |
| Industry-Specific Knowledge | ✔ | ✖ |
FAQs
Frequently Asked Questions
We partner with early-stage to mid-size pharmaceutical, biotech, OTC, dietary supplement, cosmetic, and food companies—typically teams that need senior regulatory and quality leadership without adding full-time headcount.
Absolutely. We specialize in building quality management systems from the ground up—designed to meet regulatory requirements today and scale with you as you grow.
Yes. We conduct gap assessments, prepare mock inspections, and lead remediation efforts including CAPAs, deviation management, and documentation overhauls.
We serve companies in pharmaceutical, biotech, OTC, dietary supplement, cosmetic, and food manufacturing—anywhere FDA and global regulatory compliance is required.
Engagements are tailored to your needs, but typically include a discovery call, gap analysis, prioritized roadmap, hands-on execution (systems, documentation, training), and ongoing support.