Enquirer Consulting Group
Zachary Betts | Sanai | October 2026
As of 14 Oct 2026
This page maps the US organizations that buy AI for regulatory, quality and manufacturing documents, sorted by type and size, with who usually signs off at each.
The groups follow your own site, which names drug makers, biotech companies, contract research and manufacturing organizations, and the submission routes device makers take with the FDA. Your site describes search across a company's own documents, automated authoring of submission, CMC and quality documents, document control and audit support, built for life sciences teams.
Counts are for the whole US and are rough on purpose. Contract research and manufacturing organizations share industry codes with other firms, so they carry no clean public count here.
Companies by staff size, US wide. Your buyers are the teams that write and defend the documents a drug, biologic or device needs to reach the clinic and the market.
| Group | Organizations in the US | Under 20 staff | 20 to 99 | 100 to 499 | 500 or more |
|---|---|---|---|---|---|
| Drug makers (pharmaceutical preparations) | about 1,200 | about 660 | about 220 | about 170 | about 130 |
| Biologics makers (vaccines, blood products and other biological products) | about 290 | about 150 | about 51 | about 32 | about 61 |
| Biotech research and development companies | about 4,900 | about 4,000 | about 600 | about 240 | about 130 |
| Contract research and contract manufacturing organizations | no clean public count | ||||
| Medical device makers (electromedical devices and surgical and medical instruments) | about 1,900 | about 1,200 | about 360 | about 170 | about 200 |
US firm counts by industry code, banded deliberately.
Your site speaks to each function on its own terms, so most companies have two people to reach. One is the head of the function that carries the document load, and the other owns the filing or inspection date.
| Group | Who usually signs off | What they need to hear from Sanai |
|---|---|---|
| Drug makers | The VP or head of regulatory affairs; the VP of quality; the head of CMC | Submission documents built from their own data in FDA and EMA formats, checked against current guidance, with a full audit trail |
| Biologics makers | The head of CMC or process development; the VP of quality | CMC sections drafted from batch records and process data, and investigation and CAPA packages closed sooner |
| Biotech companies | The CEO or chief development officer at a small company; the head of regulatory or clinical development as an IND nears | A filing ready document set from the team they already have, with their data never used to train the model |
| Contract research and manufacturing organizations | The VP of quality; the head of regulatory services; the site head | Consistent documents across many client programs and sites, and cleaner tech transfer records between sites and partners |
| Medical device makers | The VP of regulatory affairs; the VP of quality | Premarket submissions assembled and checked against FDA guidance, and audit preparation done from the documents they already hold |
The trigger is usually a date, such as an IND, NDA or BLA filing, a CMC module for a scale up, or an inspection or audit on the calendar. Your own site ties its onboarding slots to the next submission deadline and the next inspection, which is the same moment a buyer starts looking.
The functional head starts the search. Before anything is signed, IT, validation and security review the platform, and in this market their first questions are about 21 CFR Part 11, SOC 2 and whether the customer's data trains the model. Your site answers those questions on its home and platform pages. Larger companies usually prove a tool in one function before they extend it across teams.
The people who usually sign at the groups above, one a company. Work emails and phone numbers checked on Oct 14, 2026.
| Name | Role | Company | Where | Phone | |
|---|---|---|---|---|---|
| Karen Gutekunst | VP Regulatory Affairs | Illumina | San Diego, CA | kgutekunst@illumina.com | +1 858 666 7162 |
| Ajit Narang | VP, Head of CMC | ORIC Pharmaceuticals Inc. | San Francisco | ajit.narang@oricpharma.com | +1 818 744 6956 |
| Jichao Jay Kang | Executive Director, Head of CMC and External Manufacturing (cell and gene | Legend Biotech | Princeton, NJ | jay.kang@legendbiotech.com | +1 609 919 3439 |
| Shahram Katousian | Vice President, Head of CMC | enGene | Rancho Santa Fe, CA | skatousian@engene.com | +1 805 551 4113 |
| Aleksandar Cvetkovic | Head of CMC Drug Substance Technical Development & Operations | Civica Rx | Newberry, FL | aleksandar.cvetkovic@civicarx.org | +1 706 254 0692 |
| Tao Wu | Executive Director and Head of CMC | Kumquat Biosciences Inc. | San Diego, CA | +1 404 680 3189 | |
| Daniel Watson | SVP, Head of CMC | BBOT | Boulder, CO | daniel.watson@bbotx.com | +1 704 596 2506 |
| Mehdi Kazemzadeh-Narbat | Director of Regulatory Affairs | MCRA, an IQVIA business | Irvine, CA | mkazemzadeh@mcra.com | +1 857 222 1125 |
| Nancysabel Garcia | Director of Regulatory Affairs for New Markets | BeiGene | Chicago, IL | +1 954 588 7207 | |
| Arugadoss Devakumar | Head of Quality Control | Abzena | Oceanside, CA | arugadoss.devakumar@abzena.com | +1 812 391 2391 |
Built from public federal business statistics and the company's own website, counts banded deliberately.
If a walk-through is useful, pick a time at cal.com/ecg.
Prepared by Dan Reeves, dan@enquirerconsulting.com.