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Pharmaceuticals

The History of The Food and Drug Administration (FDA)

The History of The Food and Drug Administration (FDA)

In 1906 the Pure Food and Drug Act (Dr. Wiley’s Law) was passed by the Congress and signed by President Theodore Roosevelt, bringing the governing body of the Food and Drug Administration (FDA) into existence. The first commissioner of the FDA was Dr. Harvey Washington Wiley, who previously was the chief chemist of the USDA Bureau of Chemistry [1]. Previously to the FDA, the Bureau of Chemistry regulated food safety. The implementation of the FDA was the first comprehensive consumer protection agency in the federal government [1]. The first glimpse into what would eventually become the FDA, was the U.S Pharmacopeia which was started back in 1820 and sought to standardize drugs [2].

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.

Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments…

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.

Regulation of MedTech Products in India

Regulation of MedTech Products in India

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.

Internal Audit Readiness

Internal Audit Readiness

Internal audits within the life science industry serve to evaluate a company’s internal controls to ensure compliance with laws and regulations for the safety and efficacy of products or services. Internal audits are performed by qualified individuals who do not have direct responsibility for the area that is being audited. Audits may be an anxiety-inducing word but can become much more inviting through efficient preparation, and results from an audit may even be used as powerful tools to continuously improve on one’s QMS.

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