Pharmaceuticals

With expertise in regulatory, quality, and compliance, as well as operations and clinical services, EMMA International is your single-source pharmaceutical 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.

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.

Pharmaceutical Timeline

Drug Development

With our partnered laboratories and in-house engineers, EMMA International’s pharmaeutical consulting services play 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 pharmaceutical consulting services 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 with our expert pharmaceutical consulting services.

Learn more about post-market compliance.

Pharmaceutical Consulting Focus Areas

Aseptic Technique and Processes

Our team of experts is dedicated to providing comprehensive support for organizations aiming to enhance their aseptic processes. We offer tailored training programs, robust compliance guidance, and practical solutions to ensure your team adheres to the highest standards of aseptic practice.

Environmental Monitoring

At EMMA International, we understand that effective environmental monitoring is vital for ensuring the safety and quality of pharmaceutical products. Our specialized team provides comprehensive support to help organizations establish and maintain robust environmental monitoring programs. We offer expert guidance on best practices, regulatory compliance, and data analysis to monitor critical parameters in your facility. From air quality assessments to surface sampling protocols, we empower your team with the tools and knowledge needed to mitigate risks and uphold product integrity.

Annex I

At EMMA International, we understand the complexities of achieving compliance with Annex I requirements for sterile medicinal products. Our experienced team offers specialized support to help pharmaceutical companies navigate the stringent regulations outlined by the European Medicines Agency (EMA). We provide comprehensive assessments, gap analyses, and tailored strategies to ensure your facilities, processes, and documentation meet the latest standards. From training staff on best practices to implementing effective quality control measures, we empower your organization to enhance product safety and efficacy.

Clean Rooms

At EMMA International, we specialize in supporting pharmaceutical and biotech companies in optimizing their clean room environments. Our team provides tailored solutions to ensure your clean rooms meet stringent industry standards and regulatory requirements. We offer comprehensive assessments, best practice guidelines, and training programs focused on contamination control and operational efficiency. From design and validation to routine monitoring and maintenance, we help you create a compliant and effective clean room environment.

Compounding

EMMA International is committed to enhancing the quality and safety of pharmaceutical compounding practices. Our team of experts provides comprehensive support to help organizations adhere to the highest standards of compounding, ensuring compliance with regulatory and state-level requirements. We offer tailored training programs, guidance on best practices, and assessments to optimize your compounding processes. From facility design and equipment validation to contamination control and quality assurance, we empower your team to produce safe, effective compounded medications. We can also support with States Boards of Pharmacy registrations for your facility.

Investigations

Our experienced team offers tailored solutions to enhance your investigation processes, ensuring compliance with industry standards and regulatory requirements. From root cause analysis to corrective action plans, we provide comprehensive support to identify, investigate, and resolve issues effectively. We also assist in documenting findings and implementing improvements to prevent recurrence, fostering a culture of continuous quality enhancement. Our team can support whether you need to completely revamp your process, or simply just need extra hands.

Data Integrity

EMMA’s team provides comprehensive support to help organizations establish robust data integrity frameworks. We offer guidance on best practices, risk assessments, and compliance strategies to safeguard your data throughout its lifecycle. From implementing secure electronic systems to conducting thorough audits and training, we empower your team to maintain accurate, reliable, and compliant data.

DSCSA Compliance

Our expert team guides pharmaceutical companies through the complex requirements for serialization, product tracing, verification, and reporting, helping to secure the pharmaceutical supply chain from manufacturer to patient. With customized strategies, we address everything from system design to data management and audit readiness, making it easier for companies to meet DSCSA standards and reduce risks.