Nordhavn 62-Pendana

28/07/2021

WHEN TO CHANGE DRUG LABELING?

21/07/2021

NDA REGULATORY SERVICES – [NDA] NEW DRUG APPROVAL PROCESS IN USA IN 2020

Although all countries have a different regulatory procedure for new drug approval and market a particular drug worldwide, the drug has to pass through the Marketing Authorization Application (MAA) of different countries. As USA plays an essential role worldwide in distribution and marketing drugs,....

17/07/2021

505(b)(2) - The New Regulatory Pathway for NDA

What is 505(b)(2)?

10/06/2021

What is the helpfulness of a Pharmaceutical regulatory consulting company?

When you are dealing with pharmaceutical matters, you can also take help from the Pharmaceutical regulatory consulting services that are very effective for the company to complete each and every regul...

21/05/2021

Value of Registries in Post-Marketing Surveillance

Post marketing surveillance is the process of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.

14/05/2021

Things to Know Before Hiring a Medical device Consultant

The role of a medical device consultant is to identify the available options, take necessary corrective actions and prepare ways to deal with FDA to help the medical device manufacturers before introducing any device to the market. Read more https://pharmdevgroup.com/things-to-know-before-hiring-a-m...

17/04/2021

https://bit.ly/3sqkza7 Know about Pharmacokinetics in drug development

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10/04/2021

Know the importance of 505(b)(2)

The 505(b)(2) is the extension of the law, The Drug Price Competition and Patent Term Restoration Act of 1984. It is being used to know the workability of the medicine. Here are some usefulness pr the effectiveness of the law so that the certification of the medication can be done correctly. Visit h...