What is CRDMO? A Complete Guide to Contract Research, Development & Manufacturing Services
Why CRDMO Matters in Modern Pharma
In today’s rapidly evolving pharmaceutical landscape, time-to-market, regulatory compliance, and cost-efficiency are more critical than ever. As pharma companies seek to streamline drug development and manufacturing, CRDMOs (Contract Research, Development & Manufacturing Organizations) are emerging as essential partners.
Pharmaffiliates, with over two decades of global expertise, leads this shift, offering end-to-end CRDMO solutions that support research, development, scale-up, and regulatory compliance under one roof.
What is CRDMO? Understanding the Model
A CRDMO combines the functions of a CRO (Contract Research Organization) and a CDMO (Contract Development and Manufacturing Organization). Rather than fragmenting the drug development process across multiple vendors, CRDMOs offer a single-point solution from early-stage research to commercial manufacturing.
CRDMO = CRO + CDMO + Regulatory Expertise
By centralizing all stages of pharmaceutical development, CRDMOs help reduce handover delays, maintain data continuity, and improve regulatory readiness throughout the drug lifecycle.
Core Services Offered by a CRDMO
At Pharmaffiliates, our CRDMO service portfolio is built to support pharmaceutical and biotechnology clients across the globe. We offer:
- Custom Synthesis & Impurity Profiling
From small molecules to complex reference standards, our labs are equipped to scale up production efficiently. - Analytical Method Development & Validation
ISO 17025-compliant laboratories ensure precise and reproducible results. - Process Development & GMP Manufacturing
Pilot-to-production scale services backed by USFDA and WHO-GMP certifications. - Regulatory & Documentation Support
End-to-end CMC documentation, stability studies, and global dossier preparation.
Explore our CRDMO services in detail.
How CRDMO Differs from CDMO and CRO
While CDMOs and CROs focus on specific phases of drug development, a CRDMO offers a fully integrated solution that combines research, development, manufacturing, and regulatory support under a single contract. This improves efficiency, consistency, and accountability.
Comparison Table
|
Feature |
CRO |
CDMO |
CRDMO |
|
Research (Discovery, Preclinical) |
Yes |
No |
Yes |
|
Development & Manufacturing |
No |
Yes |
Yes |
|
Regulatory Support |
Partial |
Partial |
Yes |
|
One-Point Coordination |
No |
No |
Yes |
For pharma companies focused on cost efficiency, reduced risks, and speed to market, CRDMOs are the ideal solution.
Why Choose Pharmaffiliates as Your CRDMO Partner
With a presence in over 90 countries, a team of 130+ scientists, ISO certifications, and USFDA-compliant infrastructure, Pharmaffiliates is a trusted CRDMO partner for pharmaceutical innovators globally.
We offer:
- Expertise in impurity reference materials & analytical development
- Seamless scale-up from lab to commercial batch production
- Fully integrated regulatory documentation support
Get in touch to discuss your project, request a quote, or explore our GMP-compliant CRDMO solutions tailored to your molecule.
Frequently Asked Questions (FAQ)
What does CRDMO stand for in pharmaceuticals?
CRDMO stands for Contract Research, Development, and Manufacturing Organization, representing an integrated model that unifies the services of both a CRO (Contract Research Organization) and a CDMO (Contract Development and Manufacturing Organization). It offers a fully integrated model combining research, development, and GMP manufacturing under one umbrella.
How is a CRDMO different from a CRO or CDMO?
A CRO focuses on research. A CDMO focuses on development and manufacturing. A CRDMO combines research, development, manufacturing, and added regulatory expertise for end-to-end drug development.
What services does Pharmaffiliates provide as a CRDMO?
Pharmaffiliates offers custom synthesis, impurity profiling, method development, GMP manufacturing, and regulatory documentation, all through ISO and USFDA-compliant facilities.
Is a CRDMO model suitable for startups?
Yes. CRDMOs provide small and mid-sized pharma companies access to world-class R&D, manufacturing, and compliance capabilities without heavy investment.
