TERMS & CONDITIONS
Last Updated: December 2nd, 2025
Services Overview:
Vision V Tech LLC shall deliver visual inspection (VI) compliance and quality services on a retained basis per described Tier Level selected by the client. The services include but not limited to: Creating VI Programs, Conducting Gap Assessments, Defect Composition, Defect Categorization Analysis, SOP drafting (VI related), Knapp Studies Documentation Development (Protocols & Engineering Studies), Inspector Training/Qualification documents, Mock Audits and Regulatory Response Support.
Unlimited scope on any tier. All executions are out of scope and must be engaged on a time and material or lump sum basis via RFQ (request for quote).
Term and Commitment:
Minimum 3-year term purchase (no service provided prior purchase order received)
No early termination of the 3 years term; Client remains liable for full remaining fees/no refunds.
Services are remote-first to minimize costs; on-site work is tier-limited and requires 30 days' notice to schedule an on-site visit (14 with a rush surcharge of 10% off the first year).
Payment Terms
Term paid in advance via wire/ACH
10% discount if two terms are purchased at front (6 years), non-refundable.
Extra on-site days billed in advance at tier-specific rates
Travel expenses (business class flights >4 hours, hotel, car rental, per diem at cost + 12% admin fee).
Tier 1: Standard Tier ($52,000 Annual Fee)
Tier-Specific Services and Limits
Resources: Shared (up to 2 seniors handling 12–14 clients).
Response Guarantee: 10 business days.
On-Site Days Included: 0 (extra at $2000/day + travel).
Core Services: Unlimited remote and high level guidance access to gap assessments, defect categorization, SOP drafting, Knapp Study design (remote only), training materials, and regulatory updates. No dedicated lead or execution.
Best For: Clinical-stage companies or smaller CDMOs with low-volume injectables.
Additional Rules: Unused services do not roll over. Maximum 400 billable remote hours/year; excess requires upgrade.
Tier 2: Professional Tier ($88,000 Annual Fee) – Most Popular
Tier-Specific Services and Limits
Resources: Semi-dedicated (1 senior lead + shared support, handling 7–9 clients).
Response Guarantee: 5 business days.
On-Site Days Included: 5 (8-hour days, portal-to-portal; rollover up to 2 days; extra days at $2,000/day + travel).
Core Services: Unlimited remote and high level guidance access to gap assessments, defect categorization, SOP drafting, Knapp Study design (remote only), training materials, and regulatory updates. Assessments, mock audits. No Execution.
Best For: Mid-size companies with commercial injectables requiring occasional on-site support.
Additional Rules: On-site convertible to remote at 1:1.5 ratio (e.g., 1 day = 12 remote hours).
Tier 3: Enterprise Tier ($148,000 Annual Fee)
Tier-Specific Services and Limits
Resources: Dedicated lead + shared support (handling 4–5 clients).
Response Guarantee: 48 hours.
On-Site Days Included: 12 (rollover up to 3 days; extra at $2,000/day + travel).
Core Services: All Standard and Pro services + dedicated project management, custom risk assessments (FMEA), AQL justification for new products, and mock regulatory responses. No execution.
Best For: Large pharma with complex portfolios or high-risk products needing rapid, tailored support.
Additional Rules: Includes 4 quarterly check-ins and 1 annual on-site program audit.
Tier 4: Strategic Tier ($215,000+ Annual Fee)
Tier-Specific Services and Limits
Resources: Fully dedicated team (lead + 1–2 juniors, handling 2–3 clients).
Response Guarantee: 24 hours.
On-Site Days Included: 20 (4 rollover; extra at $2,900/day + travel).
Core Services: All Enterprise services + bespoke projects (e.g., multi-site harmonization). Unlimited access, including after-hours support for emergencies. No execution.
Best For: Industry leaders with mission-critical injectables demanding white-glove, innovative solutions.
Additional Rules: Custom pricing based on scope ($215,000 base + add-ons).
