Analytical Development & QC Capabilities to Support Commercial Partners
Coating Place provides analytical development and quality control services to support pharmaceutical products from formulation development through commercial manufacturing. Operating within a quality system designed to support FDA-regulated manufacturing, our analytical team delivers reliable, scientifically sound data that helps ensure product quality, regulatory compliance, and patient safety.
Why Partner with Coating Place?
Responsive Customer Support: More than a testing laboratory, Coating Place serves as an integrated analytical partner. Our analytical scientists work closely with your team to understand project goals and benchmarks. Rather than adding another layer between you and your data, our team acts as a direct contact for all analytical and technical questions.
Rapid Turnaround Times: We understand that analytical results drive critical development, validation, and manufacturing decisions and are committed to delivering timely, high-quality results.
Integrated Development & Manufacturing Expertise: Unlike standalone testing laboratories, our analytical team collaborates directly with formulation development, manufacturing, quality, and technical services teams, enabling faster development cycles, efficient technology transfer, and seamless support from development through commercialization. This close integration is what allows our commercial manufacturing platforms to run with confidence.
Representative Analytical Capabilities
Pre-formulation development testing (e.g., excipient compatibility studies)
Analytical method development, validation, transfer, and verification, including phase-appropriate method validation
Hold-time studies and ICH-compliant stability studies from early development through product registration
Product development, product registration, and process validation support
Raw material, in-process, and finished product release testing
Laboratory investigation support, including OOS investigations
Selected Analytical Technologies
Coating Place utilizes a range of analytical technologies to support development, registration, and commercial manufacturing activities, including:
Potentiometric Titration
Laser Diffraction Particle Size Analysis
Microscopy & Imaging
Compendial and wet chemistry testing (e.g., pH, appearance, and identification testing)
HPLC (UV, RI, PDA)
GC
Dissolution Testing
FTIR
Coulometric and Volumetric Karl Fischer Titration
Flexible Analytical Solutions
Pharmaceutical programs often present unique analytical challenges that extend beyond standard testing platforms. Supported by dedicated metrology personnel, Coating Place has a demonstrated track record of partnering with customers to evaluate, implement, qualify, and maintain new analytical technologies when project requirements demand specialized capabilities.
This collaborative approach allows customers to access the analytical solutions needed to support product development, registration, and manufacturing while maintaining continuity within a trusted analytical partnership.
In addition, our network of qualified contract laboratories provides access to complementary testing services beyond our in-house capabilities, allowing customers to benefit from broader analytical support while maintaining Coating Place as a central point of coordination and technical oversight.
Supporting Commercial Manufacturing at Scale
Our analytical and QC capabilities don't exist in isolation, they're built to support the same commercial manufacturing operations that make Coating Place a full-service CDMO partner. As products move from development into commercial production our in-house analytical team provides the release testing, in-process monitoring, and investigational support needed to keep manufacturing on schedule without compromising quality or compliance. For customers, this means a single, integrated partner for both the manufacturing and the analytical oversight behind it, reducing the coordination burden that comes with managing separate vendors for each function.
Summary
Whether supporting formulation development, registration activities, process validation, or commercial manufacturing, Coating Place provides the analytical expertise, operational flexibility, and collaborative partnership needed to advance pharmaceutical products efficiently while maintaining the highest standards of quality and compliance.