EMMA International is a consulting group that specializes in providing regulatory, quality, and compliance services to companies in the life sciences industry. Founded in 2012 and headquartered in Bingham Farms, Michigan, EMMA International has established itself as a trusted partner for medical device, pharmaceutical, and biotechnology companies, helping them navigate complex regulatory environments and ensure compliance with global standards.
Key Services Offered by EMMA International:
- Regulatory Affairs: EMMA International assists clients in preparing and submitting regulatory submissions to health authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory bodies worldwide. We help clients with regulatory strategy, submissions, and compliance assessments.
- Quality Systems: EMMA International helps companies establish and maintain robust quality management systems (QMS) to meet regulatory requirements. We offer services such as QMS development, implementation, training, and auditing to ensure quality and compliance.
- Compliance Services: EMMA International conducts compliance assessments and audits to identify and address potential issues, ensuring that clients adhere to regulatory standards. We assist in preparing for regulatory inspections and responding to findings.
- Clinical Services: For medical device and pharmaceutical companies, EMMA International offers support in designing and managing clinical trials, ensuring compliance with Good Clinical Practice (GCP) guidelines.
- Training and Education: EMMA International provides training programs and workshops on regulatory and quality topics to help companies stay informed and up to date on industry best practices.
- Risk Management: We assist in identifying, evaluating, and mitigating risks associated with product development, manufacturing, and regulatory compliance.
- Post-Market Surveillance: EMMA International helps clients establish post-market surveillance and vigilance systems to monitor product safety and performance post market release.
- Supplier Management: We offer guidance on selecting, qualifying, and managing suppliers to ensure the quality and safety of components and materials used in manufacturing.
- Supply Chain and Manufacturing: EMMA International assists companies in optimizing their supply chain and manufacturing processes while maintaining compliance with regulatory requirements.
EMMA International’s team of experienced consultants includes experts in regulatory affairs, quality management, compliance, and other specialized areas. We work closely with our clients to understand their unique needs and challenges, providing tailored solutions to help companies navigate the complex and highly regulated life sciences industry.
In a sector where adherence to regulatory standards and quality control are paramount, EMMA International consulting group plays a crucial role in helping life sciences companies meet regulatory requirements, maintain product quality, and ensure patient safety. Our services contribute to the overall success and integrity of products in the healthcare and life sciences markets.