Pharmaceuticals

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.

Pharmaceutical Timeline

Drug Development

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.

Learn more about product development.

Preclinical Studies

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.

Learn more about preclinical studies.

Regulatory Strategy

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.

Learn more about our regulatory consulting.

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.

Learn more about regulatory submissions.

Clinical Investigations

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.

Learn more about clinical investigations.

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.

Learn more about QMS Development.

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.

Pharmacovigilance

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.

Move your pharmaceuticals forward with EMMA International. Speak with one of our experts to learn more.

Ready to learn more about working with us?

Pharmaceutical Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.
Benefits of a QMS

Benefits of a QMS

Many companies do not understand the benefits of having a structured Quality Management System (QMS). A QMS is a system that documents procedures, processes, and responsibilities to achieve quality objectives and policies1. Quality management systems can be utilized in many industries especially the pharmaceutical and medical device industries, to provide structure for all processes at a facility.

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