Audits & GMP Compliance
Find gaps before regulators do.
- Internal audits and gap assessments
- Supplier and CMO/CRO audits
- Mock FDA inspections and inspection readiness
- Inspection response, 483 and CAPA support
Contract Quality & Regulatory Consulting · California
Quality and compliance support that keeps your product moving.
Flexible, on-demand QA, RA, and compliance expertise for medical device, pharmaceutical, and biotech companies. Embedded with your team or working remotely, from audit preparation to full quality system builds.
01 · Services
Four ways I help life science teams.
Short engagements or long-term support. You get senior-level expertise without adding permanent headcount.
QMS Build & Remediation
Build, remediate, or right-size your quality system.
- ISO 13485 and FDA QMSR (21 CFR Part 820) alignment
- SOPs, work instructions, and forms
- CAPA, deviations, nonconformances, and change control
- Document control, training, and management review
Regulatory: FDA & EU MDR
Clear, defensible submissions and strategy.
- 510(k), De Novo, and PMA support
- EU MDR gap assessments and technical documentation
- Regulatory strategy and pathway analysis
- Labeling review, complaint handling, and post-market support
Validation & Data Integrity
Right-sized validation, ready for review.
- Computer system validation (CSV / CSA)
- Process, equipment, and cleaning validation
- Data integrity assessments
- Risk management (ISO 14971, ICH Q9)
02 · Why work with me
Senior judgment, applied where it matters.
Frameworks are easy to find. What you are paying for is experience and clear decisions.
Senior-level, hands-on
You work directly with an experienced consultant, not a junior team behind a senior name.
Right-sized for your stage
Systems built to fit your product, risk, and company size, rigorous where regulators look and lean where speed matters.
Clear scope and fees
A written scope, timeline, and fee before work begins, so there are no surprises.
Confidential and collaborative
NDAs are standard. I work as an extension of your team and leave you with documentation you can own.
03 · Industries
Built for regulated life science companies.
Medical Devices
Class I to Class III devices, software as a medical device, and combination products.
Pharmaceuticals
Drug product and API manufacturers, packagers, labs, and distributors.
Biotech
From clinical-stage startups to commercial-ready organizations building their first quality system.
04 · Working together
Flexible ways to engage, and a simple process.
Project-based
A defined scope with clear deliverables and a fixed fee, such as a QMS build, a validation package, or a submission.
Ongoing support
Part-time QA/RA leadership on a retainer or hourly basis, embedded with your team on-site or remote.
Audit & inspection support
One-off audits, mock inspections, and help preparing for or responding to regulatory inspections.
Discover
A short call to understand your product, stage, and the problem to solve.
Scope
A clear written scope, timeline, and fee. No surprises.
Deliver
Hands-on work: audits, documents, remediation, or submissions.
Transfer
Your team gets the knowledge and documentation to sustain the result.
05 · About
Experienced, practical, and easy to work with.
Since 2010, I've supported quality assurance, quality control, and regulatory affairs efforts for medical device and pharmaceutical organizations in various capacities. That experience spans QC and analytical chemistry, sterile and aseptic manufacturing, ISO 13485 quality systems, MDSAP and internal audits, CAPA investigations, and supplier and contract laboratory oversight. I hold a Master's degree in Regulatory Affairs.
QStead Group formalizes that background into a dedicated consulting practice. I've been on the inside of the labs and manufacturing floors these systems govern, not just reviewing them from the outside, and I bring that hands-on perspective to startups and small-to-mid-sized companies that need experienced quality support but don't yet have a full internal quality organization.
- Based in California, serving companies statewide and remotely nationwide
- Master's degree in Regulatory Affairs
- Confidentiality and NDAs standard on every engagement
06 · Common questions
Questions clients ask first.
What do you do?
I provide contract quality assurance, regulatory affairs, and compliance support to medical device, pharmaceutical, and biotech companies: audits, quality management systems, FDA and EU MDR regulatory work, and validation.
Do you work on-site or remotely?
Both. I am based in California and can work on-site with California teams, and I support companies elsewhere remotely.
How are engagements priced?
Project work is quoted against a written scope and fee before it starts. Ongoing support can be arranged on an hourly or retainer basis.
Can you help us prepare for an inspection?
Yes. I can run gap assessments and mock inspections, and support preparation and responses. Regulatory outcomes depend on many factors, so I do not promise specific results.
Is my information kept confidential?
Yes. NDAs are standard on every engagement.
How quickly can we get started?
Start with a short discovery call. Timing after that depends on scope and my current availability, and I will tell you upfront.
07 · Contact
Let's talk about your project.
Share a few details and I will follow up within one business day to schedule a no-obligation intro call.
- Emailqsteadgroup@yahoo.com
- Phone(619) 718-1853
- LocationCalifornia, USA · On-site and remote