Pharmaceuticals & Life Sciences

Fractional CTO for Pharmaceuticals & Life Sciences

Fractional CTO for pharmaceuticals & life sciences, built around the constraint that defines the sector: GxP validation means every system change needs documented evidence before it reaches production.

Regulations in scope
5
Systems we integrate
5
Typical first release
6 weeks

What changes when it is pharmaceuticals & life sciences

Part of the mandate is to make ourselves unnecessary. We plan for your full-time hire from the start rather than building dependency.

In pharmaceuticals & life sciences, GxP validation means every system change needs documented evidence before it reaches production. That single fact reshapes how fractional cto has to be built here, the guardrails, the approval points and the evidence trail are design inputs rather than things bolted on before go-live.

The workload we are most often asked to take on first is adverse event intake and coding, usually integrated against LIMS. Every engagement opens with a measurement: the cycle time, the cost per transaction, or the error rate we are being asked to move.

Built by engineers who ship production systems, not by a practice that subcontracts the build. We hand over with runbooks, tests and a team that knows how it works, not a dependency.

The sector constraints we design around

Defining constraint
GxP validation means every system change needs documented evidence before it reaches production
Regulations in scope
CDSCO · US FDA 21 CFR Part 11 · EU GMP Annex 11 · GxP validation · ICH guidelines
Systems of record
LIMS · QMS · eTMF · SAP · pharmacovigilance databases
Where we usually start
batch record review

Fractional CTO workloads in pharmaceuticals & life sciences

  • batch record review
  • adverse event intake and coding
  • regulatory dossier assembly
  • deviation and CAPA drafting
  • literature monitoring

What is included

  • Architecture and technical debt assessment with a prioritised plan
  • Engineering hiring, role definition, screening and interview design
  • Vendor and platform selection with explicit criteria
  • Delivery process and quality standards your team can sustain
  • Board and investor technical reporting in plain language
  • A handover plan for when you hire full-time

Questions from this sector

Can an AI system be GxP validated?

Yes, with a documented validation approach, IQ/OQ/PQ, defined intended use, change control and evidence of consistent performance. We build the validation pack alongside the system, not afterwards.

How do you handle 21 CFR Part 11?

Audit trails, electronic signatures, access control and record integrity designed in from the start, because retrofitting them is effectively a rebuild.

How much time do we get?

Typically one to three days a month, scaled to what is happening. Fundraising, a migration or a hiring push warrant more; steady state needs less.

Will you help us hire a permanent CTO?

Yes, and we consider it part of the job. Defining the role, screening and handing over cleanly is the intended end state.

Can you do technical due diligence?

Yes. Both sides. Assessing a target before acquisition, or preparing your own codebase for an investor's review.

Fractional CTO for pharmaceuticals & life sciences, worth a conversation?

Tell us the workload and the regulation it sits under. We will tell you what is realistic.

Or email bd@dtrasglobal.com · call +91 74118 77878