As science and technology advance, pharmaceutical development has become more demanding than ever. No matter how complex the therapy or how expansive the data, EMMA International helps you meet critical milestones on time and on budget.
With expertise in regulatory, quality, and compliance, as well as operations and clinical services, EMMA International is your single-source consulting solution. Our in-house experts, combined with our scientific partners, ensure a seamless experience that complies with all standards as well as your protocols.
With our partnered laboratories and in-house engineers, EMMA International plays a strategic role in drug development from day one. Using a Functional Service Provider model, we assist with developing test methods, performing literature/scientific reviews, and more.
From identifying the correct animal model and ensuring good laboratory practices are followed during the study, to generating the final clinical report, EMMA International provides support during all phases of your pre-clinical studies.
All successful projects start with a plan. Our experts help you determine how to classify your product, any preclinical and quality system requirements, and how to budget for regulatory activities, among other questions.
Pre-Investigational New Drug Application
The Investigational New Drug (IND) application shapes your path to market. EMMA International will help you prepare for the pre-IND meeting with the FDA, as well as prepare your submission package.
Regulatory approval depends on successful clinical trials. EMMA International can not only help prepare the entire suite of regulatory documents, we’ll also help shape your clinical trials. Calling on our strategic partners, we’ll help you with site monitoring, GCP auditing, and other critical components.
Quality System Development
EMMA International’s proprietary methodology is compliant, lean, integrated, and customizable (CLIC™). From that framework, we set up your QMS to integrate with international requirements. You’ll not only be set up for success during pre-approval inspections and surveillance audits, you’ll gain a competitive advantage.
QMS Development and Maintenance
Ensure your quality management system (QMS) suits your organizational structure. We will maintain any and all aspects of your QMS, from CAPA processes and supplier management activities to regulatory inspections.
As you turn your attention to new pipelines and projects, EMMA International will monitor the safety of your existing product. Our scientific experts oversee post-market surveillance and vigilance reporting.
Learn more about post-market compliance.