Services

Our Services

Let us take your Life Science company to the next level.

FDA COMPLIANCE CONSULTANT IMAGE

FDA Compliance

Keeping up with the constantly changing regulatory world is a daunting task. As the nation’s leading firm in FDA compliance matters, we help Life Science companies with:

  • 483 responses
  • Warning Letter responses
  • Remediation strategies
  • Labeling and website reviews
  • Audits and gap analyses
  • Mock FDA inspections
  • Regulatory submissions

Quality Systems

Our main niche! We specialize in designing, building and implementing quality systems for organizations of all sizes across the Life Sciences industry. We 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 a multitude of ISO standards. As such, one of our primary specialties is designing, building and implementing “Integrated QMSs”. An integrated QMS is one that satisfies the requirements of multiple ISO standards and/or regulatory requirements.

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Regulatory Affairs

Our strategic pathways! We leverage an approach that is designed to deliver high quality, cost-effective solutions for our customers. Our focus is to accelerate the regulatory approval process for firms in the Life Sciences industry. Our regulatory affairs services include both pre-approval 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.

ISO Certifications

Have you lost a current or potential customer due to not having a particular ISO compatible Quality Management System (QMS)?  Has a current customer informed you that without obtaining a particular ISO certification, you will be removed as an approved supplier?
We can provide you with the consulting support you need to implement the desired QMS and attain certifications through 3rd party registrars.
We have the in-house expertise in:

ISO 9001

ISO 17025

ISO 13485

ISO 14971

OHSAS 18001

ISO 14001

IATF 16949

ISO 15189

ISO 22000
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Consulting on Regulatory Compliance

Quality and Regulatory Reviews

We offer a unique service to our clients who would like an expert to review their quality and/or regulatory needs, and provide a foundational roadmap for their next steps.
Quality and Regulatory Review Consultations give you the essential pieces to start achieving your regulatory or quality goals, so you can move forward with a better understanding of what it is you need to accomplish to reach regulatory compliance.

CYBERSECURITY

Cybersecurity is affecting all areas of business, and the Life Sciences industry is no exception. With important and sensitive intellectual property to protect, a multitude of regulations, and a complicated legislative landscape to navigate, cybersecurity is no longer something that needs to be considered at a later date. It needs to be a critical part of your business now. Let the experts at EMMA International help you assess your cybersecurity business needs today.

Corporate Compliance Programs

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 in bringing that drug to market.