Contact

Request a Technical Briefing

We work with quality, operations, and technology leaders at pharma and biotech companies that are deploying — or planning to deploy — AI in GxP environments. If that describes your situation, we would like to understand it.

Tell us about your initiative.

This is not a sales call. Our briefings are technical conversations — a candid assessment of your AI validation posture and what it would take to qualify your systems for GxP use.

We respond to all briefing requests within 2 business days.

What to expect

1
Briefing request reviewed We review your submission and confirm a 45-minute time slot within 2 business days.
2
Technical briefing (45 min) A candid assessment of your AI validation posture. We come prepared with questions specific to your regulatory environment and manufacturing context.
3
Validation posture summary We follow up with a written summary of our assessment and a proposed engagement scope if appropriate. No pressure, no timeline.

Who we work with

Our engagements are best suited for:

  • → VP Quality, Chief Quality Officers responsible for AI audit readiness
  • → VP Manufacturing / Technical Ops scaling AI-assisted batch operations
  • → CTOs and technical leads deploying AI tools in GxP grey areas
  • → Companies under FDA or EMA inspection preparation

Direct inquiry

hello@nexgengxp.com

Headquarters

Boston, Massachusetts