01
The people who sell it do it
Every engagement names the individual doing the work before you sign, and if that person has to change, you approve the replacement. We are not a pyramid with partners at the top and contractors underneath.
Founded 1999 · Independent · San Mateo, California
Why TekTeam?
Because the senior people who answer your first email are the senior people who do the work — and because we will tell you when the cheaper path is the right one, even when it costs us the engagement.
Regulatory, CMC, quality, clinical and pharmacovigilance consulting for drug, biologic and device developers. From the first pathway question through submission, launch and post-market safety.
1999
Founded
Tech Team, LLC has been privately held and independent every year since. No parent company, no channel partners, nothing in a catalogue we need you to buy.
30 years
Minimum, senior staff
Every senior member of the team brings at least thirty years in the medical products industry in their own area of expertise. That is the floor, not the average.
Principals
On the file, not just the pitch
Small enough that the person who scopes your work is the person who delivers it. Senior in the room and junior on the file is the standard failure mode of this industry.
The answer, in detail
Eight claims you can test
Not positioning. Each of these is something you can check in the first three weeks of working with us — and hold us to if it turns out not to be true.
02
We tell you what the cheap option costs
When you choose the less expensive path, you get a written section setting out exactly what you are giving up and the conditions under which we would tell you to change course. No quiet omissions.
03
Nothing to sell you but the work
We are not a CRO, a CDMO, a notified body or a software vendor, and we take no referral fees. There is nothing we are quietly steering you toward, so advice costs us nothing to give and everything to get wrong.
04
We will tell you no
If a pathway will not work, you hear it in week one while it is still cheap to hear. Paid confirmation of a decision already made is not a service we offer.
05
Written deliverables
You receive protocols, plans, procedures and dossier sections you can file, defend and hand to an investigator — not slideware summarising a conversation you already had.
06
Precedent, not guesswork
Since 1999 we have learned which arguments work with which reviewers, and which quietly fail. Historical precedent is the cheapest regulatory strategy available.
07
Built so the next step isn't a redo
We structure records and documentation to the standard you will need at the next stage, not just this one — so scaling up or migrating later is a mapping exercise rather than starting over.
08
Your date, not ours
Submission windows, board meetings, first-patient-in and audit slots do not move to accommodate a consultant. We plan backwards from your date and flag slippage early, in writing.