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

Incorporating GDP through Lean Six Sigma

Incorporating GDP through Lean Six Sigma

GDP – far-reaching within all GxP-compliant organizations, and yet it can be a challenging point for many during audits. GDP, or Good Documentation Practices, are essential to maintaining an effective QMS. In a previous blog post, we touched on GDP, ALCOA+, and recommendations for successful GDP practices. In this post, we’re going to take a deeper dive into GDP, the governing regulations, and tips on consistently maintaining GDP.
How does FDA regulate Complementary and Alternative Medicine

How does FDA regulate Complementary and Alternative Medicine

Ayurveda, which is a traditional system of medicine, originated more than 3000 years ago. This field of medicine pays larger emphasis on building strength of mind and body to cope with different kinds of stressors and infections.[i] There are studies which suggest that ayurveda can reduce pain, manage with symptoms of type 2 diabetes, etc.
FDA Warning Letters Are Public Information

FDA Warning Letters Are Public Information

For a medical device organization, a Warning Letter from the FDA is the worst kind of publicity.  It is an open disclosure of how poorly your organization complied with specific regulatory requirements. 
Role Definition for Team Success

Role Definition for Team Success

Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”).[i] This Bill overhauls the pre-independence legislation enacted by the Central Legislative Assembly, the Drugs and Cosmetics Act, 1940,[ii] (“D&CA”) which is the primary legislation for regulation of drugs, biologics and medical devices at the moment.

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