Early access
It arrived.
Your request is with us. Nothing else is needed from you today.
What we have: your name, your work email, your company, your role, the dosage forms you manufacture, and how your batch records are prepared today. Nothing else, and nothing enriched from anywhere else.
No master formula, bill of materials or batch record has been sent to us, and none should be until the step below is done.
Kinjal reads the ones about the record. Mitesh reads the ones about the system. Usually within two working days, and always from a person — there is no queue, because there are two of us.
What happens next
Five steps. Three of them are ours.
We read it
Both of us, not a filter. If the fit is not there we say so plainly rather than going quiet.
We reply
Usually within two working days. The reply comes from Kinjal or Mitesh, never from a sequence.
A confidentiality agreement, if you need one
Most quality units do. Ours is short, or we sign yours. This is the step that takes the longest, and it is worth starting before you need it.
You send two documents
One approved master formula, and your current blank record format for the same product. Read the next section before you do.
We draft it, then walk it line by line
The record comes back in your own format, watermarked Draft, with every signature block empty. Then we go through it with you and whoever reviews these records at your plant.
Before you send anything
A master formula is a controlled document. We know.
You cannot email one out of your plant on your own authority, and we would think less of your quality system if you could. This is the step that stalls, so here is what it actually takes.
The agreement comes first
Nothing controlled changes hands until a confidentiality agreement is signed and there is a defined handling procedure. That is in our terms of use, and it is there for you rather than for us.
A redacted copy is fine
If your quality unit prefers, redact the API name, the strengths, anything commercially sensitive. We need the structure of the document, not your formulation.
Bring one colleague
The walk-through is worth more with the person who actually reviews these records in the room. They will ask the questions we want asked.
While you wait
Nothing to do, but something to read.
The nine regulations behind a batch manufacturing record, each with what it asks of one. It is the reference we write everything from, and it is the page worth forwarding to whoever has to approve sending us a document.
Changed your mind? Write to p.mitesh@pharmasynapse.ai and we delete your submission. No reason needed, and we do not ask for one. The full position is in the privacy policy.