Analytical Services
Building the Analytical Foundation for Development and Manufacturing
Analytical development is essential to understanding and controlling drug product quality. At Corealis, we design and implement analytical methods that characterize APIs and drug products, monitor stability, and ensure consistency throughout development and manufacturing.
Our teams provide the data required to support formulation optimization, GMP manufacturing, and regulatory submissions, ensuring your program progresses with confidence.
Our Analytical Development Workflow
Method Transfer & Evaluation
We transfer and assess existing analytical methods from the client, ensuring suitability for development and GMP environments.
Method Development & Optimization
Analytical methods are developed or refined to support API characterization and drug product evaluation.
Validation & Qualification
Phase-appropriate validation ensures methods meet regulatory expectations and are suitable for GMP use.
GMP Testing & Stability Programs
We perform release testing, stability studies, and ongoing analytical support throughout clinical development.
Typical Timeline
From Molecule to Clinical Supply
A structured development pathway designed to accelerate oral solid dose programs from early formulation to GMP clinical manufacturing. While timelines vary depending on API complexity and formulation strategy, a typical development pathway may include:
Pre-Formulation & Method Evaluation:
1-2 weeks
Prototype Development 5-8 Prototypes:
4-5 weeks
Engineering Batch:
2-3 weeks
GMP Batch Preparation & Planning:
2 weeks
GMP Manufacturing, Release and QA Review:
6 weeks
Report:
4-6 weeks
Typical duration:
4–6 months or less.
*Timelines may vary depending on program complexity and development strategy.
Key Analytical Instrumentation
Corealis leverages advanced analytical technologies to ensure accurate and reliable data generation.
Representative instruments include:
UPLC / HPLC systems
Gas chromatography (GC)
Dissolution testing systems
UV spectrophotometry
Karl Fischer titration systems
ICP-OES for elemental analysis
Stability chambers (ICH conditions)
Wet chemistry and analytical support tools
These instruments enable comprehensive characterization, testing, and quality control of APIs and drug products.
See Our Development Facilities
Corealis operates more than 60,000 square feet of integrated formulation, analytical, and GMP manufacturing facilities located in Laval, Canada.
Visiting our laboratories provides an opportunity to meet the scientists supporting your program and see firsthand how our teams collaborate to solve complex formulation challenges.
FAQ
What is the role of analytical development in drug development?
Do you support both API and drug product testing?
Can Corealis transfer existing analytical methods?
What types of analytical methods do you develop?
Do you provide GMP analytical testing?
How long does analytical method development take?
Learn more how Corealis can support your drug product development needs.
