Ongoing Executive Quality Advisory
Defined advisory support for sustained FDA compliance and quality-system decisions
Strategic Compliance RetainersLimited Availability
Premium retainers for firms needing high-touch, flexible FDA compliance leadership without hiring in-house.
Growth Retainer – Strategic Partner Tier
25 hours/month · No rollover · 6 month term · Remote with onsite availability
This premium retainer is designed for firms needing high-touch, flexible FDA compliance leadership without hiring in-house.
Core Services Include:
- Direct access to Dr. Joseph Lambert (Former FDA investigator/CDER Office of Manufacturing Compliance Officer)
- Inspection readiness planning
- Attend client meetings for input from FDA expert on manufacturing and quality unit issues
Additional Benefits:
- SOP and QMS compliance reviews
- Priority scheduling & email access
- Monthly progress call with KPI summary
- Additional hours beyond the 25-hour monthly allowance billed at $300/hour
Branding Use Option Available
This plan includes the option to use Dr. Lambert's name, FDA credentials, or image in public materials (e.g., proposals, websites, BD decks) for an additional 15% branding premium.
Branding rights offer clients the reputational value of former FDA/CDER authorship on public enforcement actions (e.g., warning letters to Viatris (formerly Mylan), Sun, Granules), enhancing credibility in proposals and investor discussions.
Branding rights are limited to one client only at a time.
🔒 Only two strategic retainers are offered at once. Contact us to apply.
Retainers are filled on a first-confirmed basis. Waitlist available if current capacity is reached.
Annual Advisory Retainer
40 hours prepaid remote
Designed for early-stage or occasional clients needing flexible but lower-volume regulatory compliance support. This package is prepaid and receives priority over general consulting hours or flex pack.
- Quarterly check-ins and regulatory document review
- Unused hours expire at the end of each annual contract period
- Additional hours beyond the 40-hour annual allowance billed at $395/hour
- Attend client meetings for input from FDA expert on manufacturing and quality unit issues
Not eligible for branding rights or priority scheduling benefits.