Services

FDA COMPLIANCE

Keeping up with constantly changing regulations is a daunting task. As the nation’s leading FDA compliance firm, we help companies with 483 responses, warning letter responses, remediation strategies, labeling and website reviews, audits, gap analyses, mock FDA inspections, regulatory submissions, and more.

QUALITY SYSTEMS

We design, build and implement quality systems for organizations of all sizes, and are very flexible in the types of services we provide, from smaller limited assignments to long-term complex projects. We have expertise with U.S. & international regulatory requirements, as well as ISO standards.

ISO CERTIFICATIONS

Have you lost a customer for not having a particular ISO compatible Quality Management System (QMS)?  Has a customer informed you that without obtaining a particular ISO certification, you will be removed as an approved supplier? We provide the support you need to implement QMS and attain certifications.

REGULATORY AFFAIRS

 Our regulatory affairs services include both pre- and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.

CYBERSECURITY

Cybersecurity affects all areas of business, and the Life Sciences industry is no exception. With important and sensitive intellectual property, a multitude of regulations, and a complicated legislative landscape, cybersecurity needs to be a critical part of your business now.

CORPORATE COMPLIANCE

Whether your company is commercializing its first drug or growing its portfolio, building an effective compliance infrastructure is good business. Managing the risks of commercializing a drug helps protect the significant investment your company has made.

Ready to talk?

EMMA International is a leading FDA compliance consulting firm. We provide cost-effective solutions for FDA regulatory affairs, compliance services, regulatory filings and submissions. Our expertise includes medical devices, biotechnology and pharmaceutical services.

We’d love to talk to you about how we can help your business succeed.