Industries
Life Sciences & Pharma Consulting
From Lab to Patient, Faster
Clinical operations stalled by spreadsheets. Quality systems that fail audits. ifBash delivers FDA-compliant ServiceNow that connects trials, quality, and safety on one validated platform.
The problems we get called about.
Clinical Operations
Study start-up, site activation, and issue management as governed workflow, with the audit trail produced by the system rather than assembled afterwards.
Quality & Compliance
Deviations, CAPAs, and change control on a validated platform, with electronic records and signatures configured to your validation approach.
Pharmacovigilance
Adverse event intake, triage, and submission tracked against the reporting obligations that apply to your products and markets.
Where AI actually helps here.
Agents are useful for regulated document work where a human still signs: drafting the narrative, retrieving the applicable SOP with citations, and flagging where the evidence is incomplete.
Where it does not help, we will say so. An agent added to a broken process just makes the same mistakes faster.
The questions procurement actually asks.
21 CFR Part 11 governs electronic records for the US market and remains the right reference for anyone filing with the FDA. For a manufacturer or distributor operating in the Gulf, the equivalent authority is the SFDA in Saudi Arabia and MOHAP in the UAE. Vision 2030 includes localising pharmaceutical and medical device manufacturing, which means validation and quality systems being stood up in-region — often for the first time, and usually against a deadline tied to a licence.
We map platform configuration to the control families below and hand over the mapping with the build. That is a description of how we work, not a certification claim — where a framework requires an accredited audit, that audit is yours or your assessor's, and we say so in writing.
- SFDASaudi Arabia
- The Saudi Food and Drug Authority licenses products, facilities, and distribution. GxP records, deviation handling, and batch documentation need to survive an SFDA inspection, which is a different evidence set from an FDA one even where the underlying process is identical.
- MOHAPUAE
- Product registration and pharmacovigilance reporting run through the Ministry of Health and Prevention. Adverse event intake with regulator-specific SLA timers is straightforward to model once the reporting deadlines are known.
- 21 CFR Part 11 / EU Annex 11US / EU
- Still relevant, and unchanged on this page — most Gulf manufacturers export, and an export market brings its own electronic-records regime with it. Systems validated once against the stricter of the two are cheaper to keep validated.
- PDPLSaudi Arabia / UAE
- Applies to patient and trial subject data. Where a study spans jurisdictions, cross-border transfer conditions differ, and that difference belongs in the data model rather than in a policy document nobody reads.
We won't name clients we can't name.
Sector pages usually carry logos and percentages. Ours don't, because most of that work sits under agreements that do not permit it — and inventing a number to fill the space is worse than leaving it empty.
If you want a reference in life sciences, ask. Where a client has agreed, we will introduce you directly under NDA.
See what we can show youConnects to Medidata Rave, Veeva Vault CTMS/eTMF, and Oracle Clinical through Integration Hub. Protocol deviations flow into ServiceNow within hours.
Working in life sciences?
Tell us the problem in your own words. Back inside two working days: an approach, a sequence, and who would do the work.