Verus Advisors — FDA & Compliance Offers
Fixed Price • Fast Turnaround • Regulator-Ready
FDA deadlines don't wait. Neither do we.
🔴 Emergency Response Services
FDA Warning Letter Rapid Response
Full diagnostic review within 48 hours of receiving a Warning Letter.
- Full Warning Letter analysis
- Gap assessment vs FDA expectations
- Enforcement risk ranking
- Clear remediation roadmap
- Go / No-Go recommendation
FDA Warning Letter – Complete Response Package
Full FDA-ready written response with CAPA framework and submission support.
- FDA-ready written response
- Corrective & Preventive Action (CAPA) framework
- Documentation remediation plan
- Regulator-facing language (no red flags)
- Submission support through FDA portal
FDA Form 483 Remediation Package
Observation-by-observation analysis with audit-defensible CAPA documentation.
- Observation-by-observation analysis
- Root cause mapping
- CAPA documentation
- Management response language
- Audit-defensible structure
510(k) Failure / RTA Recovery
Strategy and predicate package to recover from rejection or Refuse to Accept.
- RTA or rejection analysis
- Predicate device strategy
- Gap analysis vs FDA expectations
- Submission correction roadmap
🟡 Compliance & Reinstatement Services
Amazon FDA Compliance Reinstatement
Get suspended or threatened Amazon listings reinstated with full FDA compliance.
- FDA classification assessment
- Listing & claims correction
- Required FDA registrations/listings
- Amazon appeal narrative
- Supporting compliance documentation
MoCRA Cosmetics Compliance – Done For You
Complete MoCRA compliance setup including facility registration and product listings.
- Cosmetic facility registration
- Product listings
- Ingredient review (high-risk flags)
- Label compliance check
- FDA-ready records
OTC Product FDA Setup
Complete FDA setup for over-the-counter drug products.
- OTC classification confirmation
- Establishment registration
- Drug listing (SPL)
- Label compliance review
- Risk memo for enforcement exposure
OTC Listing
File an OTC drug product listing (SPL) for a single product.
- Single-product OTC drug listing (SPL)
- Structured data entry & validation
- Submission-ready package for FDA portal
MoCRA Listing
Submit a MoCRA cosmetic product listing for a single product.
- Single-product MoCRA cosmetic listing
- Ingredient & category entry support
- Submission-ready confirmation details
NDC Labeler Code Registration
Register your company as an FDA Labeler and obtain an NDC Labeler Code.
- NDC Labeler Code acquisition
- FDA Registration & Drug Listing portal setup
- Label formatting template
🔵 510(k) Submission Services
Special 510(k) Submission New
Abbreviated 510(k) for design/tech modifications to an existing predicate device.
- Eligibility screening + predicate match check
- 510(k) summary + device description drafting
- Risk and performance justification
- Submission via eSTAR
510(k) Exemption Assessment & Filing Popular
Determine whether your device qualifies for 510(k) exemption and file appropriately.
- Product classification & exemption check
- Registration & listing support
- Claims/indications compliance review
- Documentation package & FDA filing
510(k) Roadmap & Gap Assessment
Identify classification, predicate options, and testing/documentation gaps.
- Device classification & exemption check
- Predicate screening + comparison matrix
- Testing & documentation gap list
- Gantt-style timeline & risk areas
⚫ Advisory & Diagnostic Services
FDA Compliance Diagnostic Call
60-minute live product and situation review with next-step recommendations.
- Live product / situation review
- Regulatory classification clarity
- Risk exposure assessment
- Next-step recommendation
Monthly Advisory Retainer
Ongoing FDA and compliance advisory for consumer and medical product companies.
- Up to 4 hours of advisory & document reviews
- Slack/Email priority channel
- Quarterly planning checkpoint