RelyAInt for CDMOs
One platform.
Every client.
Every authority.
CDMOs operate under the most complex compliance environments in the industry — multiple clients, multiple regulatory frameworks, multiple inspection bodies, simultaneously. RelyAInt gives your QA team a structured platform to manage it all without waiting for an external consultant.
Multi
Client regulatory mapping — per client, per authority
48hrs
From evidence upload to inspection-ready findings
12+
Global regulatory frameworks covered
Self
Serve — your QA team runs the full workflow
FDA · EMA · MHRA · SAHPRA · TGA
Multi-client GMP compliance
Tech transfer ready
Client audit defensible
The CDMO compliance challenge
The compliance complexity
only CDMOs face
Manufacturing organisations manage one compliance programme. CDMOs manage many — simultaneously, across clients, jurisdictions, and inspection bodies. Traditional consultancy was never built for this.
Multi-client regulatory mapping
Each client brings their own regulatory framework, their own inspection authority, and their own audit expectations. Your QA team must maintain separate compliance programmes for each — without a structured platform, this creates dangerous gaps.
GMP segregation and cross-contamination control
Client auditors increasingly scrutinise how CDMOs maintain GMP segregation across product lines. Demonstrating documented, inspection-defensible controls for each client relationship is a growing regulatory expectation.
Tech transfer documentation gaps
Technology transfers are among the highest-risk events in a CDMO's compliance lifecycle. Incomplete or poorly documented transfers are a primary source of FDA and EMA observations — and a common trigger for client audits.
Simultaneous multi-authority inspections
CDMOs serving global clients may face FDA, EMA, MHRA, and SAHPRA inspections in the same quarter — each with different documentation expectations, inspection styles, and corrective action timelines.
Client audit readiness — always on
Unlike manufacturers, CDMOs cannot predict when a client will request an audit. Audit readiness must be maintained continuously across all client accounts — not built reactively in the weeks before a scheduled visit.
RelyAInt is built for this
Our regulatory library includes a dedicated CDMO control batch — 1,400+ controls mapped across all major authorities, with CDMO-specific GAP categories including multi-client GMP, tech transfer, and client audit readiness.
Your QA team can run all of this within the platform — no external consultant required.
Self-serve assessments, AI-classified findings, corrective actions, and inspection-ready reports — delivered within 48 hours of evidence upload.
Platform mapping
Compliance mapped by client, geography,
and authority
RelyAInt structures CDMO compliance across three dimensions — so your QA team can run targeted assessments for any client, in any market, against any regulatory authority.
Client-level compliance
One assessment per client relationship — structured and defensible
Each client brings their own regulatory requirements, audit expectations, and compliance standards. RelyAInt lets your QA team run a dedicated GAP assessment for each client relationship — mapping your current controls against what that specific client requires.
Client-specific regulatory requirement mapping — what does this client need from you?
GAP identification against client audit checklist requirements
Corrective actions assigned to your QA team with evidence upload workflow
Client audit-ready report generated within 48 hours
GMP segregation controls documented per client product line
Example scenario
US-based biotech client requests pre-audit compliance review
CDMO QA team runs a client-specific GAP assessment against FDA 21 CFR requirements. AI classifies 14 findings — 2 Critical, 6 Major, 6 Minor. Team confirms classifications, generates corrective actions, and delivers an audit-ready report — all within 48 hours.
Example scenario
Three active clients — three separate compliance programmes running simultaneously
CDMO with FDA, EMA, and MHRA clients uses RelyAInt to maintain three separate assessment workflows in parallel — each mapped to the relevant client's regulatory framework, with separate findings registers and action trackers per client.
Geographic compliance mapping
Jurisdiction-specific assessments for every market you serve
Each geographic market your CDMO serves has distinct regulatory requirements, inspection styles, and documentation expectations. RelyAInt maps your compliance posture against the specific requirements of each jurisdiction — not generic GMP principles.
North America — FDA 21 CFR Parts 210, 211, 820 and guidance documents
Europe — EMA EU GMP Annexes, MHRA post-Brexit requirements
Africa — SAHPRA, NAFDAC, ZAZIBONA, EAC regulatory frameworks
Asia-Pacific — TGA, PMDA, ANVISA requirements
International — WHO GMP, ICH Q-Series, PIC/S cross-border standards
Example scenario
CDMO expanding into African markets alongside existing FDA compliance
CDMO serving US clients begins manufacturing for a South African client. QA team runs a SAHPRA-specific GAP assessment alongside their existing FDA programme — identifying delta requirements and new controls needed without disrupting current operations.
Example scenario
Post-Brexit MHRA compliance delta assessment
CDMO previously compliant with EMA requirements runs a targeted MHRA delta assessment to identify specific UK post-Brexit divergences. 8 additional controls identified and corrective actions generated within the platform — no external consultant required.
Authority-specific compliance
Inspection-ready for every regulatory authority — simultaneously
Different regulatory authorities have different inspection styles, documentation priorities, and finding classifications. RelyAInt's regulatory library is built with authority-specific controls — so your team can prepare for an FDA inspection differently from an EMA audit, even for the same facility.
FDA — 21 CFR-aligned controls, 483 observation pattern library, CAPA requirements
EMA — Annex 11, EU GMP, data integrity guidance, QP requirements
MHRA — UK-specific post-Brexit divergences from EMA requirements
SAHPRA — South African GMP requirements and inspection expectations
WHO — Prequalification requirements for generic and biosimilar manufacturers
Example scenario
FDA and EMA inspections in the same quarter
CDMO facing an FDA PAI and EMA GMP inspection within 60 days runs parallel authority-specific readiness assessments. FDA findings register and EMA findings register maintained separately — each with authority-specific corrective actions and documentation requirements.
Example scenario
WHO prequalification readiness for generic manufacturer
CDMO supporting a client's WHO prequalification submission runs a targeted WHO GMP assessment. 11 findings identified and corrective actions generated — inspection-ready documentation package delivered to the client portal within 48 hours.
Case studies
How CDMOs use RelyAInt
Two anonymised case studies showing how CDMO QA teams used the platform to close compliance gaps, prepare for inspections, and manage multi-client regulatory programmes — without external consultants.
Mid-size CDMO · Europe
Multi-client FDA and EMA compliance programme — managed simultaneously within 48 hours
A mid-size European CDMO serving three pharmaceutical clients — one US-based requiring FDA compliance, two EU-based requiring EMA compliance — needed to maintain separate, inspection-defensible compliance programmes for each client without increasing headcount.
3×
Client compliance programmes running in parallel
48hrs
From evidence upload to audit-ready report
31
Findings identified across all three programmes
0
External consultants engaged
The challenge
The QA team was managing three separate compliance programmes using spreadsheets and shared drives. Client audit requests arrived with 2–3 weeks notice. Each audit preparation took 3–4 weeks of manual work. The team had no structured way to maintain continuous audit readiness across all three client relationships simultaneously.
Outcome: All three client audit requests responded to within the platform. Critical findings closed within 3 weeks. QA team now maintains continuous audit readiness for all clients — audit preparation reduced from 3–4 weeks to 48 hours.
Finding breakdown
Critical4 findings — GMP segregation documentation and audit trail gaps
Major14 findings — tech transfer documentation and change control gaps
Minor13 findings — SOP alignment and periodic review scheduling
Small CDMO · Africa
SAHPRA inspection readiness and WHO prequalification GAP assessment — completed without external support
A small South African CDMO with limited internal QA capacity was preparing for a SAHPRA GMP inspection while simultaneously supporting a client's WHO prequalification submission. With a two-person QA team and no budget for external consultants, they needed a structured, self-serve compliance workflow.
2×
Parallel assessments — SAHPRA and WHO simultaneously
10wks
Full inspection readiness achieved within timeline
3
Previous Major observations — all closed with evidence
95%
Less cost vs. equivalent external consultancy engagement
The challenge
The QA team had no structured framework to identify which specific controls were required for SAHPRA versus WHO GMP. Previous inspection had resulted in 3 Major observations. The team needed to close those findings, prepare for re-inspection, and simultaneously support the WHO prequalification GAP assessment — with a two-person team and a 10-week timeline.
Outcome: SAHPRA re-inspection resulted in zero repeat observations. WHO prequalification GAP assessment delivered to client on schedule. QA team of two managed the entire compliance programme within the platform — no external consultant engaged at any stage.
Finding breakdown
Critical2 findings — data integrity controls and audit trail configuration
Major9 findings — including 3 carryover observations from previous inspection
Minor7 findings — documentation gaps and training record currency
Platform fit by size
Built for every CDMO size
Whether you have a two-person QA team or a dedicated compliance department, RelyAInt scales to your capacity and complexity.
Small CDMO
Under 100 staff · 1–2 person QA team
Limited internal QA capacity, high compliance risk relative to team size, typically serving 1–3 clients. Every compliance hour counts — structured tooling replaces the need for expensive external consultants.
Primary use cases
Inspection readiness assessment before first regulatory inspection
Client audit preparation — structured findings register delivered in 48 hours
Data integrity programme assessment — ALCOA+ gap identification
WHO or SAHPRA prequalification readiness
Expert review escalation when senior assurance is needed
Recommended plan
Starter — 5 credits/mo
$1,500/mo
Mid-size CDMO
100–500 staff · 3–10 person QA team
Established QA function, multiple active client relationships, operating across 2–4 regulatory jurisdictions simultaneously. Compliance volume outpaces team capacity — parallel structured workflows are essential.
Primary use cases
Multi-client compliance programmes running in parallel — separate findings per client
FDA and EMA simultaneous inspection preparation
Tech transfer documentation GAP assessments for new client onboarding
GMP segregation controls documentation across product lines
Continuous audit readiness — all clients, always on
Recommended plan
Growth — 10 credits/mo
$2,500/mo
Large CDMO
500+ staff · Dedicated compliance department
Complex multi-site operations, 5+ active client relationships, global regulatory footprint. Internal compliance infrastructure exists but speed, consistency, and cross-site standardisation are the primary gaps.
Primary use cases
Multi-site compliance standardisation across all manufacturing locations
Custom regulatory workflows tailored to specific client and authority combinations
Fixed-price deep-dive GAP assessments for complex pre-PAI situations
Cross-jurisdiction delta assessments for new market entry
Expert review for complex data integrity or CSV findings requiring senior sign-off
Recommended plan
Enterprise — 20 credits/mo
$4,500/mo
Ready to get started
Your QA team can run their first CDMO assessment within 48 hours.
No external consultants. No blank pages. No 8-week wait. Upload your evidence, run your assessment, confirm AI-classified findings, and generate an inspection-ready report — all within your client portal.
Self-serve — your team runs the workflow
48hr findings delivery
Expert escalation on demand
Cancel anytime
1,400+
GxP controls including dedicated CDMO batch
48hrs
From evidence upload to inspection-ready report
12+
Global regulatory frameworks — FDA, EMA, SAHPRA and more
95%
Less cost per assessment vs. traditional consultancy
Try first
Try the compliance engine — free, no sign-up
Describe your CDMO compliance situation and get a preliminary AI-assisted assessment in seconds. See how the platform structures compliance work before committing to a plan.
No sign-up required
Results in seconds
Preliminary findings and recommendations
Expert follow-up available on request
Talk to us
Discuss your CDMO compliance context with the team
Have specific questions about multi-client programmes, geographic mapping, or platform fit for your CDMO? Talk to the RelyAInt team — we'll help you identify the right approach for your situation.
Response within 24–48 hours
No obligation or sales pressure
Confidential — your context stays with us
Platform demonstration available on request
Platform notice: RelyAInt is a self-serve compliance platform. Your team's qualified employees run all assessments and govern all determinations. AI classifies severity and risk — your team confirms every finding before it is published. Expert review by a RelyAInt consultant is available on demand and is billed separately per engagement. All outputs are preliminary and must be confirmed by qualified human reviewers within your organisation.