The Role of Analytical Method Development in CRDMO Success
Why Analytics Is a Pillar of Pharmaceutical Development
In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP manufacturing, precise analytical data is essential for making informed decisions and meeting stringent regulatory expectations.
For CRDMOs (Contract Research, Development & Manufacturing Organizations), analytics is not just a support function; it's central to success. In an integrated model like Pharmaffiliates’, analytical services are built directly into every stage of development, enabling seamless progression from molecule profiling to manufacturing validation.
What is analytical method development and validation?
Analytical method development refers to the creation of reliable procedures used to detect, quantify, and assess the purity and stability of pharmaceutical substances. Once developed, these methods must be validated to confirm accuracy, reproducibility, specificity, and sensitivity under defined parameters.
Analytical method validation, as required by global regulatory bodies (FDA, EMA, ICH), ensures that the results generated by a method are trustworthy and fit for their intended purpose, especially during critical decision points such as formulation, batch release, or stability studies.
Key method parameters include:
- Linearity and Range
- Accuracy and Precision
- Specificity and Robustness
- Detection and Quantitation Limits
At Pharmaffiliates, all method validation is performed under ISO 17025-compliant laboratory systems, ensuring traceability and data integrity across all results.
Pharmaffiliates’ CRDMO Lab Services: Built for Precision
Our CRDMO model integrates fully equipped analytical labs within the larger development pipeline. This ensures that method development and validation are not siloed; they’re part of a coordinated, compliant process.
Our key analytical capabilities include:
- HPLC, GC, LC-MS/MS, FTIR, UV-Vis spectrometry
- Method development for impurities, residual solvents, and degradation profiling
- ICH stability testing and validation documentation
- Method transfer and lifecycle management
- Analytical support for process validation and scale-up
With over two decades of experience in impurity reference standards, Pharmaffiliates delivers consistent results across a wide spectrum of active molecules and complex APIs.
Explore our Certified Analytical Laboratory Services
Why Validated Methods Drive GMP Manufacturing
Once a method is validated, it becomes an essential tool in GMP-compliant manufacturing. Whether it’s in-process quality checks or final batch release, method consistency ensures products meet predefined specifications with each cycle.
Validated analytical procedures reduce the risk of variability, accelerate regulatory submissions, and provide confidence during scale-up. In a CRDMO model, where development and manufacturing are managed under one roof, method validation enables faster handover and reduces cost duplication.
Integrated CRDMO + Lab Services: A Competitive Advantage
The success of a CRDMO depends on how seamlessly research, development, analytics, and manufacturing operate together. At Pharmaffiliates, our ISO 17025-accredited lab services form a backbone of our integrated CRDMO offering, helping clients:
- Eliminate delays during formulation scale-up
- Ensure regulatory-ready documentation
- Maintain data continuity from R&D to production
- Meet international quality benchmarks with confidence
Whether you're optimizing a method for impurity profiling or validating release criteria for scale-up, our team ensures analytical accuracy without compromise.
Get in touch with Pharmaffiliates to explore how our CRDMO lab services can accelerate your molecule’s success.
Frequently Asked Questions (FAQ)
What is analytical method validation in pharma?
Analytical method validation ensures that a developed method produces reliable, consistent results for its intended use, critical for product quality and regulatory compliance.
Why is analytical development important in CRDMOs?
In CRDMOs, analytics underpins every phase of development. It enables faster formulation decisions, supports GMP compliance, and provides traceable data for regulatory filings.
Are Pharmaffiliates' lab services ISO 17025 certified?
Yes, all analytical activities are conducted in ISO 17025-accredited laboratories, ensuring high precision, accuracy, and data reproducibility.
Can analytical methods be transferred across locations?
Yes. At Pharmaffiliates, method transfer and lifecycle management are part of our CRDMO service, ensuring that validated methods can be reliably used across manufacturing units.
