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.


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

Innovating Healthcare: Theranostics

Innovating Healthcare: Theranostics

Theranostics are innovative, and beneficial to patients in that they find the cancer cells and also deliver targeted radiation to those cells all within the same treatment. Historically, patients would need to undergo at least two different medical procedures, one to find the cancer cells (by the use of something like a PET or X-Ray), and then another to actually receive the treatment via chemotherapy, photon, or proton therapy.
Enhancing Quality and Compliance: Remediation Services for Pharmaceutical Manufacturers

Enhancing Quality and Compliance: Remediation Services for Pharmaceutical Manufacturers

The pharmaceutical industry plays a pivotal role in safeguarding public health by producing safe and effective medications. However, maintaining the highest standards of quality and compliance can be challenging due to the complex nature of pharmaceutical manufacturing. In the pursuit of excellence, pharmaceutical manufacturers sometimes encounter issues that require expert intervention. This is where remediation services for pharmaceutical manufacturers come into play.
Navigating Deviation Investigations in the Pharmaceutical Industry

Navigating Deviation Investigations in the Pharmaceutical Industry

In the pharmaceutical industry, ensuring the safety, efficacy, and quality of medicines is of paramount importance. To achieve this, pharmaceutical companies must adhere to stringent regulations and guidelines set by the regulatory authorities. One critical aspect of maintaining product quality and compliance is the process of deviation investigations. In this blog, we will explore what deviation investigations are, why they are crucial, and how they are conducted in the pharmaceutical industry.

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