From point automations to governed AI agents that do the work
We're the go‑to services partner that designs, builds, and runs agentic systems for pharma regulatory affairs. The goal: accelerate approvals, cut resubmits, and scale RA capacity.
What is Pharma Agentic Transformation?
Positioning
A shift from static tools to governed, interoperable AI agents that perceive, reason, and act across RA workflows—connected to trusted references, constrained by your policies, and overseen by your experts.
Agents handle the heavy lift: extraction, cross‑checks, assembly, monitoring.
Humans make the calls: approval gates, overrides, and exceptions.
Every action leaves a trail: citations, diffs, and audit logs.
Architecture
The Bytebeam Agent Stack
Data & Knowledge
Connect to PIL/SmPC, CTD modules, change logs, SOPs, and accepted reference markets. Options for in‑browser processing, on‑prem, or private cloud.
Reasoning & Policy
Deterministic rulepacks + LLM reasoning aligned to SFDA/eCTD/labeling norms. Market‑aware configurations per geography.
Tools & Actions
OCR, document assembly, translation, browser automation, structured search & compare, citation, and redlining.
Orchestration & Guardrails
Human‑in‑the‑loop approvals, role‑based access, audit trails, versioning, and privacy controls. Stateless by default.
Agent Modules
Start with one agent, orchestrate many
RA Proofreader Agent (Saudi SDI)
Proofreads and auto‑fills SDI forms from PIL & SmPC inside the browser.
OUTCOME
Faster first‑pass approvals, fewer resubmits, shorter prep time.
Labeling Copilot (PIL/SmPC)
Drafts SmPC and PIL grounded in QRD templates—pulling from CTD sources, approved reference labels, and your house style.
OUTCOME
Shorter authoring cycles, compliant QRD structure, and cleaner redlines across variations and markets.
Classification Agent (KSA)
Guides product classification with structured reasoning and citations to accepted references.
OUTCOME
Lower misclassification risk and smoother regulatory paths.
CTD/eCTD Assembly Agent
Builds dossiers, manages modules/sequences, links, and checks formatting & completeness.
OUTCOME
Compress assembly timelines, reduce technical rejections.
Regulatory Intelligence Agent
Monitors client markets and benchmarks updates to your portfolio with curated alerts linking to sources.
OUTCOME
Save time, stay compliant, and be in the know.
Translation & Localization Agent
Terminology‑consistent translations (incl. Arabic) with QA vs. source labels and target norms.
OUTCOME
Faster cycles with consistent terminology and style.
Artwork Content Agent
Generates packaging copy and structured artwork content from approved labeling.
OUTCOME
Quicker label changes to print‑ready assets; fewer manual errors.
Variation & Change Agent
Tracks cross‑market changes, performs impact analysis, and drafts synchronized updates.
OUTCOME
Cleaner variations and faster synchronization.
RA Knowledgebase & SOP Agent
Answers "how do we…?" from private SOPs with links to canonical steps.
OUTCOME
Faster onboarding and standardized execution.
Pharmacovigilance Agent (AER)
Automates the extraction of drug names and adverse events from unstructured reports like emails and forms.
OUTCOME
Faster identification of safety signals, improved data quality, reduced manual effort and regulatory risk.
Clinical Trial Reporting Agent
Summarizes key findings and extracts safety and efficacy data from clinical study reports and patient-reported outcomes.
OUTCOME
Accelerated data analysis, streamlined report generation, improved data consistency for medical writing.
Quality Control Agent (SOP & Batch Records)
Validates batch manufacturing records and quality control documents against standard operating procedures (SOPs) for compliance.
OUTCOME
Reduced deviation rates, faster batch release, minimized risk of cGMP non-compliance.
MedInfo Agent (Request & Fulfillment)
Extracts key clinical questions from customer inquiries and generates data-grounded responses from an approved knowledge base.
OUTCOME
Quicker response times to health care professionals, consistent and accurate information, reduced workload on medical staff.
Market Intelligence Agent
Analyzes regulatory filings, press releases, and clinical trial databases to identify competitor activities and market opportunities.
OUTCOME
Accelerated pipeline analysis, proactive competitive intelligence, data-driven strategic planning.
Adoption
Agentic Maturity Model
Level 0
Assist
Read‑only alerts and linting; humans apply fixes.
Level 1
Copilot
Drafts & suggestions with one‑click apply; approval gates.
Level 2
Orchestrated Agents
Multiple agents hand off tasks with guardrails and audit trail.
Level 3
Autonomous with Approval
Agents execute end‑to‑end and wait at human checkpoints.
KPIs We Target
Engagement Model
Controlled Diagnostic on recent SKUs.
Pilot one agent with clear KPIs.
Scale to orchestrated agents across markets.
How we work
From diagnostic to governed agents
We keep it simple: start small, prove value, then scale. You get transparency on scope, governance, and a daily‑rate estimate before any build. The diagnostic & pilot are free for the first two weeks.
1. Discovery & Feasibility
Gain insights and assess fit
- • 30–60 min conversation to map your RA workflows and systems.
- • Identify pain points, data sources (PIL/SmPC, CTD, change logs), and constraints.
- • Define success criteria, governance needs, and a feasible first scope.
2. Evaluation & Proposal
Solution options, timeline, and estimate
- • Light technical review: data readiness, integrations, approval gates.
- • We outline the target agent(s), guardrails, and KPIs (e.g., resubmits ↓, turnaround ↓).
- • You get a plain‑English proposal with daily‑rate estimate and milestones.
3. Controlled Diagnostic & Pilot
Free 2‑week assessment + pilot
- • Run a diagnostic on a recent SKU set to baseline errors and cycle time.
- • Stand up one governed agent in a sandbox with your experts in‑the‑loop.
- • Weekly readouts: findings, diffs, and next‑step recommendations.
4. Implement, Govern & Scale
Build, integrate, monitor
- • Implement the agent(s) with approvals, audit trails, and role‑based access.
- • Integrate with your toolchain (DMS, eCTD, translation, browser automation).
- • Post‑deploy monitoring with continuous tuning against KPIs and policy updates.
Simple Pricing
$750 / resource / day
We estimate the effort (days × resources) and charge based on the estimate.
What You Get
- • Transparent scope & milestones
- • Governed agents with human checkpoints
- • Audit trails, diffs, and KPI tracking
Governance & Privacy
Designed for regulated environments
Stateless by Default
In‑browser processing for sensitive steps with no data retention.
Private Deployment
On‑prem/private cloud options with role‑based access controls.
Full Audit Trail
Approvals, citations, diffs, and audit logs for every action.
Client Success
Proven results with government partners
"Working with ByteBeam has been an exceptional experience. Their agile and well-organised team helped us transform a time-consuming, manual process into a smart, efficient workflow — saving both time and costs while ensuring quality and compliance."
Trusted by Certified Government Service Centre partners.
Next step
Introduce Agentic Transformation to your RA leadership
We'll tailor a short session to your portfolio and markets, agree KPIs, and propose a phased path to Level 2–3 maturity.