Health & life sciences

Pharma & biotech. Every word about a medicine is regulated.

Doctors, patients and inspectors each read it differently.

Pharmaceutical and biotech companies, from branded generics and biologics to CDMOs and clinical research, where promotion is tightly ruled and every claim can be audited. We build HCP portals, patient-support and trial-recruitment journeys, compliant content systems and the data behind them, with AI that drafts from approved sources and never decides.

Talk about pharma & biotech Read the rulebook
The number we move
Time from brief to medical-legal approval
Where we work in pharma & biotech
  • Branded generics
  • Speciality & biologics
  • Vaccines
  • CDMO & APIs
  • Clinical research
  • Biotech platforms
Rules mapped
7 rules · 4 areas
Disciplines that lead
TechnologyCampaign
Frameworks we build to
DPDP Act 2023 — Digital Personal Data Protection Act, 2023CERT-In Directions 2022 — Cyber incident reporting directionsISO/IEC 27001:2022 — Information security management systemsOWASP Top 10 for LLM Applications — LLM and generative AI security risksWCAG 2.2 AA — Web Content Accessibility Guidelines
A scientist in a white coat and gloves holds up a small sample at a laboratory bench
Pharma & biotechEvery claim starts as data on a bench.

Where the rules biteMap of all forty-one industries

  • Claims Advertising & claims: Shapes most of the work
  • Regulator Sector regulator: Shapes most of the work
  • Payments Payments: Sometimes shapes the work
  • Data Personal data: Shapes most of the work
  • Security Security & incidents: Often shapes the work
  • Access Accessibility: Sometimes shapes the work
  • AI AI governance: Often shapes the work

What is shifting

Promotion was rewritten, and the pack learned to speak.

A uniform marketing code, upgraded manufacturing standards, codes on the pack and a US crackdown on drug advertising all changed what a pharma brand can say and how it proves it. Each shift names what it demands, with a fact you can check.

Stacked blister packs of capsules lit in cool blue light
The pack itself now carries a code that proves it is genuine.

  1. Marketing to doctors now runs to a single national code.

    It demandsHCP journeys, events and samples designed to the code, with every interaction recorded.

    SignalThe Department of Pharmaceuticals notified the Uniform Code for Pharmaceutical Marketing Practices on 12 March 2024, covering gifts, travel, samples and medical education.

  2. The pack became an authentication tool.

    It demandsPack systems with room for codes, and patient journeys that explain how to check them.

    SignalSince 1 August 2023, the 300 drug brands listed in Schedule H2 must carry a barcode or QR code that lets anyone verify the product.

  3. Manufacturing quality moved up a level for every plant.

    It demandsQuality systems, documentation and supplier portals ready for inspection.

    SignalRevised Schedule M, notified on 28 December 2023, applied to larger firms from mid-2024 and to smaller firms granted extensions by 31 December 2025.

  4. Regulators abroad are policing drug advertising on social media.

    It demandsFair-balance risk information and disclosed influencer content in every market you promote in.

    SignalOn 9 September 2025 the US FDA announced thousands of letters to drug sponsors and about 100 cease-and-desist letters over misleading advertising.

The rulebook

Who you may tell, what you may say, and how you prove it.

India’s drug-advertising law, the marketing code, the clinical-trial and manufacturing rules, and the data and cyber rules, read for a typical programme. Your medical, legal and regulatory reviewers keep sign-off.

Frameworks we build to

  • DPDP Act 2023 — Digital Personal Data Protection Act, 2023
  • CERT-In Directions 2022 — Cyber incident reporting directions
  • ISO/IEC 27001:2022 — Information security management systems
  • OWASP Top 10 for LLM Applications — LLM and generative AI security risks
  • WCAG 2.2 AA — Web Content Accessibility Guidelines

Frameworks we design and build to — not a claim of certification.

Advertising & claims

Shapes most of the work

  1. Department of Pharmaceuticals

    Uniform Code for Pharmaceutical Marketing Practices, 2024

    Promotion to healthcare professionals must be evidence-based and balanced; gifts, travel and hospitality for HCPs are barred, samples are limited, and complaints go to an ethics committee.

    We designHCP programmes are designed without inducements, with evidence on every message and interactions recorded.

    Department of Pharmaceuticals · UCPMP, notified 12 March 2024 Official text: Uniform Code for Pharmaceutical Marketing Practices, 2024

Sector regulator

Shapes most of the work

  1. Government of India

    Drugs and Magic Remedies Act, 1954

    Bars advertising that promises to cure, prevent or treat the diseases and conditions in its Schedule, and claims of magic remedies, in any medium.

    We designA blocked-claims list built from the Schedule runs on every draft, human or AI.

    Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

  2. CDSCO, Ministry of Health

    New Drugs and Clinical Trials Rules, 2019

    Trials run with CDSCO permission, ethics-committee approval and informed consent, with compensation for trial-related injury or death.

    We designRecruitment pages and consent materials are designed in plain language and for ethics-committee review.

    New Drugs and Clinical Trials Rules, 2019 (notified 19 March 2019)

  3. Ministry of Health · CDSCO

    Revised Schedule M — good manufacturing practice

    An upgraded GMP standard for every plant: a pharmaceutical quality system, quality risk management, product quality reviews and validated computerised systems, with stronger data integrity.

    We designQuality and supplier portals are built with audit trails and data-integrity controls from the start.

    Drugs Rules, 1945 · revised Schedule M, G.S.R. 922(E), 28 December 2023

  4. Ministry of Health · CDSCO

    Schedule H2 — codes on top brands

    Makers of the 300 brands in Schedule H2 print a barcode or QR code on the label holding the product code, generic and brand names, maker, batch, dates and licence number.

    We designPack systems reserve a governed space for the code, and patient pages explain how to check it.

    Drugs Rules, 1945 · Schedule H2, G.S.R. 823(E), 17 November 2022 (from 1 August 2023)

Personal data

Shapes most of the work

  1. Ministry of Electronics and IT

    DPDP Act, 2023 and DPDP Rules, 2025

    Patient-support, trial and HCP data collected per purpose with consent, withdrawal as easy as consent, and breach reporting to the Data Protection Board.

    We designPatient programmes ask only for what support needs, with consent logged per purpose.

    DPDP Act, 2023 · DPDP Rules, 2025 (core obligations from 13 May 2027) Official text: DPDP Act, 2023 and DPDP Rules, 2025

Security & incidents

Often shapes the work

  1. Indian Computer Emergency Response Team

    CERT-In Directions, 2022

    Cyber incidents reported to CERT-In within six hours of being noticed, and ICT logs kept for 180 days.

    We designPortals and platforms ship with logging, monitoring and an incident runbook that meets the six-hour clock.

    CERT-In · Directions under section 70B(6), 28 April 2022 Official text: CERT-In Directions, 2022

Compiled 3 October 2026. Our reading of typical programmes, not legal advice. Rules change; your counsel confirms how each one applies to you.

Challenges

Where pharma & biotech loses customers and time.

What comes up first in most pharma & biotech conversations — outside, at the screen, and inside, in the operation.

Your customers

  1. Doctors short on time

    HCPs want the clinical evidence and the prescribing information in seconds, not a sales visit.

  2. Patients who need support

    Adherence, access and side-effect information in plain words, in their own language.

  3. Trials that are hard to join

    Eligibility, sites and consent explained clearly enough for patients to say yes.

Pink tablets tumble across a stainless-steel feeder bowl on a production machine
Quality is built on the line, then proved on paper.

Your operation

  1. Medical-legal review as the bottleneck

    Every asset waits for medical, legal and regulatory sign-off, often in sequence.

  2. Adverse events in every channel

    Any inbox, chat or comment can hold a safety report that has to reach pharmacovigilance.

  3. Evidence behind every claim

    Each claim needs its reference, approval and expiry tracked across markets.

What we build

The disciplines behind a typical pharma & biotech programme.

A typical programme here draws on each discipline in this mix. Every line names what it builds for the industry and links to the capability that does the work.

Leads Core Supports Share of a typical programme, by role · illustrative
  1. 01

    Technology & Intelligence

    Leads

    Claims libraries, review workflows and secure portals integrated with your CRM and safety systems.

  2. 02

    Campaign & Content Design

    Leads

    HCP and patient content produced from an approved claims library, ready for medical-legal review.

  3. 03

    Brand Design

    Core

    Brand and pack systems that hold the declarations, the codes and the portfolio architecture.

  4. 04

    AI Design

    Core

    Drafting and medical-information assistants that cite approved sources and route safety signals.

  5. 05

    Product & Experience Design

    Core

    HCP portals, patient-support programmes and trial-recruitment journeys designed for clarity and consent.

  6. 06

    Marketing Technology

    Core

    Consented HCP engagement and omnichannel journeys, recorded the way the marketing code expects.

Programmes

Map the claims and the reviewers first, then speed the content up.

The way in maps every claim, channel and approval step against the rules, and ranks the fixes by review time and by risk. Lengths are typical, never promised.

The way in

Claims and review-flow diagnostic

We map every claim, channel and approval step against the advertising law and the marketing code, and show where review stalls and where the risk sits.

Package
Sprint · Fixed fee
Typical length
2–3 weeks
It sets
Time from brief to medical-legal approval, as a baseline
  • Brand audit & diagnostic
  • Technical & code audit

What it hands over

  • A claims inventory with references and expiry dates
  • A review-flow redesign that removes sequential waits
  • A channel map of what each audience may receive
Start here

  1. 02Project · 8–12 weeks

    Claims library and review workflow

    Approved claims, references and expiry dates in one library, with a review workflow that runs medical, legal and regulatory checks in parallel.

    MovesShare of assets approved first time

    Services: Workflow automation · Content model & headless CMS · Brand check

    Enquire about Claims library and review workflow

  2. 03Milestone · 4–9 months

    HCP portal and patient-support programme

    A portal for healthcare professionals and a patient-support journey, each showing only what its audience may receive, with consent and safety reporting built in.

    MovesHCP portal engagement with prescribing information

    Services: End-to-end UX & UI design · Custom CRM or operations platform · Lifecycle journey build

    Enquire about HCP portal and patient-support programme

  3. 04Project · 8–12 weeks

    Medical-information assistant with evaluations

    An assistant that answers from approved medical information, cites its source and routes any possible adverse event to pharmacovigilance.

    MovesAnswer accuracy on an agreed evaluation set

    Services: AI knowledge assistant · AI assistant experience design

    Enquire about Medical-information assistant with evaluations

How success is measured

The number we moveTime from brief to medical-legal approval

  • Time from brief to medical-legal approval
  • Share of assets approved first time
  • HCP portal engagement with prescribing information
  • Possible adverse events routed within the agreed time

AI, under the rules

AI drafts from approved sources, a reviewer approves every word.

Each use case has an owner, an evaluation set and a log; possible adverse events always reach your pharmacovigilance team.

Use case 01

Drafting from the claims library

Measured byShare of drafts approved without changes

Tested forOWASP LLM09 · Misinformation

agent / drafting-from-the-claims-library Guarded
  1. TaskDrafts HCP and patient materials using only approved claims and their references.
  2. GuardrailCannot introduce a claim, indication or comparison the library does not hold; prescription medicines are never promoted to the public.
  3. HumanMedical, legal and regulatory reviewers approve every asset.
  4. LogEach draft stores the claim IDs and references it used.

Ships only with its evaluation set, its guardrail and an owner

Use case 02

Medical-information assistant

Measured byAnswer accuracy on an agreed evaluation set

Tested forOWASP LLM01 · Prompt injection

agent / medical-information-assistant Guarded
  1. TaskAnswers questions from approved medical information and the prescribing information.
  2. GuardrailCites its source, refuses off-label advice and flags any possible adverse event for pharmacovigilance.
  3. HumanThe medical-information team reviews flagged answers daily.
  4. LogQuestion, sources cited, answer and any safety flag.

Ships only with its evaluation set, its guardrail and an owner

Use case 03

Adverse-event triage in inboxes

Measured byReports routed within the agreed time

Tested forOWASP LLM02 · Sensitive information disclosure

agent / adverse-event-triage-in-inboxes Guarded
  1. TaskReads inbound messages and comments for possible adverse events and routes them to pharmacovigilance.
  2. GuardrailIt only flags and routes; it never closes or assesses a case.
  3. HumanPharmacovigilance assesses every flagged report.
  4. LogMessage, flag reason, routing time and outcome.

Ships only with its evaluation set, its guardrail and an owner

Work and insights

Case studies stay private until a client approves them.

No pharma & biotech client is named or described without written approval. Here is what we have written that bears on the industry.

A typical programme · composite

A speciality pharma company moved its HCP content onto a claims library where every statement carries its reference, approval and expiry, so field teams, the HCP portal and medical education draw on the same approved words.

Anonymised and illustrative: the shape a programme takes, never a named client.

Related reading

Nothing published on pharma & biotech yet. Ask us what we are seeing in the industry.

Ask us

Questions

What medical, marketing and compliance leads ask us first.

Something else on your mind? Ask us directly

Q.01Can you build HCP-only content and portals?

Yes. We design portals that verify the healthcare professional before showing promotional or prescribing content, keep patient-facing material separate, and record the interactions the marketing code asks you to.

Q.02How do you handle adverse events in digital channels?

Every channel we build — forms, chat, social listening — has a route that sends possible adverse events to your pharmacovigilance team within the time your procedures set, with the original message attached.

Q.03Will AI write our promotional material?

It drafts from your approved claims library and nothing else; your medical, legal and regulatory reviewers approve every asset before it is used.

Q.04Do you work with CDMOs and API makers?

Yes: B2B brands, capability sites, quality and supplier portals and RFQ journeys for CDMOs and API manufacturers, where inspection readiness and data integrity decide the buying.

Keep exploring

Next in health & life sciences, then every sector we cover.

All forty-one industries

Let’s build what happens next.

Tell us what you’re building. We’ll answer straight.

Book a discovery call

Three ways to start

  1. 01About 2 minutes

    A quick question

    You get A reply from a lead, not a sales queue

  2. 02About 8 minutesMost useful

    A project brief

    You get Options and a first scope after one call

  3. 03About 15 minutes

    A formal RFQ or RFP

    You get Receipt confirmed and a named bid lead

Every engagement starts with a written scope and a quote agreed before work begins. How each package is priced

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