top of page
Tags
Particulate and Spectroscopic Services
"One sometimes finds what one is not looking for."
- Alexander Fleming
Laboratory Services
Laboratory services form the bedrock of robust pharmaceutical safety and quality processes. With years of product analytical experience, Particlese has the practical knowledge to answer your most difficult questions. Partnering with leading academics in biologics means the best minds and the latest research are available for your products. Non-GMP services include:
-
Project planning and execution
-
Compatibility study planning and execution
-
Stability study planning
-
Technology assessment and recommendations
Method Consulting
If laboratory analytics are the bedrock of safe pharmaceuticals, robust method development, optimization, and qualification are the pillars supporting your organization's structure. Particlese has developed numerous methods, performed optimization and qualification, and drafted supporting ATMs for client deployment with even non-compendial techniques. Services include:
-
Method development and optimization planning
-
Method qualification planning
-
Method ATM drafting
Data Consulting
Data is the driving force for decision making in the modern pharmaceutical organization. Data quality, and the attendant interpretation thereof, requires assessment by experienced scientists, not just a printout of results. Given the hyper-specialization of professional scientists, your team may not have the knowledge to confidently judge analytical approaches and results from contract partners within regulatory requirements (ICH, ISO, etc.). Particlese gives you unfettered access to just this expertise!
-
Experimental and data quality assessment
-
Data reinterpretation
-
CMC investigational support
Document Consulting
Professional documents are an expression of your organization's focus on quality and competence. They communicate complex scientific information to decision makers, as well as regulatory authorities. Particlese's experience in authoring high-quality documents for internal and regulatory consumption can be leveraged to improve your product and meet tough timelines.​
-
Summary drafting and review
-
GMP document drafting and review
-
Publication drafting and review
-
Presentation authoring
Technology Services
Building out a modern laboratory, acquiring quality instrumentation, and staffing with capable analysts is a daunting challenge for any lab manager. Likewise, keeping up-to-date with the latest technologies and contract service offerings seems impossible. Engaging with the competence of Particlese can shortcut time-to-rollout and make you look fabulous!
-
Laboratory layout and planning
-
Instrument assessment and acquisition
-
Instrument training and deployment planning
-
Training program planning
-
Contract partner recommendations
bottom of page