CRDMO
A CRDMO takes a molecule from discovery chemistry to commercial supply under one roof. That means research data that starts outside GxP, development data that may later support a filing, and manufacturing systems held to full GMP, all linked, all audited by sponsors, and often inspected by FDA, EMA and CDSCO in the same year.
For a contract research, development and manufacturing organisation, the hard part is the boundary. Discovery work usually runs outside GxP, development work increasingly has to support a filing, and manufacturing runs under full GMP. Validation has to be sized to each stage, and data that crosses from one stage to the next has to carry its integrity with it.
Identify The Roadblocks Slowing Your Growth
These challenges compound: cycles slow, scaling gets harder, and inspection posture drifts.
Regulations We Cover
Every CRDMO engagement is mapped to the regulations your inspectors will use.
CRDMO
- FDA 21 CFR Part 11 / 210 / 211
- EU GMP Annex 11
- India Revised Schedule M
- ICH Q7 / Q9 / Q10
- 01DiscoveryELNRegistration systemResearch data with integrity, even before GxP
- 02DevelopmentELNLIMSCDSData that can support a filing
- 03Clinical supplyMESLIMSGMP from the first clinical batch
- 04Commercial manufacturingMESSCADAERPFull GMP batch records
- 05Quality and releaseeQMSLIMSOne quality system across service lines
Services & Products For CRDMO
Three Regulatory Postures Under One Roof
A CRDMO is three businesses sharing people, systems and clients. Discovery chemistry and biology mostly sit outside GxP. Development work, from process chemistry to analytical methods and clinical supply, moves steadily into GMP. Commercial manufacturing is full GMP. Treating all of it to the strictest standard wastes effort; treating all of it to the lightest one fails the first inspection.
The workable answer is risk-based scoping per stage. Each system is classified for what it actually supports, validation effort follows that classification, and the classification is revisited when a system's role changes, for example when a development LIMS starts holding data for a clinical batch.
Where Research Data Crosses Into GxP
The most common gap is not inside any one system but at the boundary between them. Results recorded in a research ELN end up in a development report; a method developed in one lab is transferred to a GMP lab; data from a non-validated system supports a GxP decision. Each crossing needs a defined check, so the data that arrives is complete, attributable and unchanged.
Making those crossings explicit, with an owner, a verification step and a record, is usually far cheaper than validating the research systems to GMP. It also gives sponsors and inspectors a clear answer to the question they increasingly ask: where did this number come from?
Answering FDA, EMA and CDSCO in the Same Year
Many CRDMOs supply the US and European markets while operating in India, which means FDA and EU inspectors alongside CDSCO. India's revised Schedule M brings domestic GMP closer to WHO and PIC/S expectations, including a pharmaceutical quality system, quality risk management and requirements for computerised systems, so the gap between the three is narrowing.
The practical approach is one evidence base built to the strictest applicable expectation, with each regulator's specific points mapped onto it. Running separate validation approaches per market on the same systems creates exactly the inconsistencies inspectors look for.
Sponsor Audits Across Service Lines
A sponsor that uses a CRDMO for discovery, development and supply will often audit all three, sometimes with different teams who expect different things. The evidence has to make sense to each of them: a research auditor asking about data integrity, a quality auditor asking about change control, a CMC lead asking about method transfer.
GxP Copilot keeps validation evidence current per system, and our leads organise it so each audit sees the part that applies to it. The result is a single quality story across the service lines, which is the thing a CRDMO is really selling.
Explore More For Regulated Life Sciences
CRDMO validation without the backlog.
Bring one system. A CRDMO validation lead shows you the package it produces.
- We reply within one business day
- We run your URS live on the call
- You get a clear plan for your system