The current picture of pharmaceutical regulatory industry is somewhat like this: globalization in emerging markets, increasing concerns of public health by health authorities and stringent regulatory guidelines to adhere to. For companies to avail the uninterrupted supply of its medical products and devices in the market, swift pre and post marketing approvals are required.
- November 25, 2015 Pharmaceuticals, Regulatory Consulting
- November 4, 2015 Medical Devices, Publishing & Submissions
Submissions scheduled for Sep 24, 2016.
Now that the second phase of UDI compliance, for Class III I/LS/LS medical devices, has been implemented, many device manufacturers, especially of Class II type, are questioning how best they could be prepared for September 24, 2016 Class II device data submission deadline.
- October 19, 2015 Regulatory Consulting, Health Authority Updates
The impact of regulatory compliance on development of pharmaceutical and life sciences products is getting convergent and complex. It takes thorough analysis and ample amount of time and resources to understand a particular guidance and its implementation to be able to get compliant as per health authorities guidelines.
- October 17, 2015 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
FDA published a guidance in May 2015 announcing a deadline for electronic submission of active DMFs. As per these guidelines, DMF holders are required to submit the baseline submission that generally includes the Module 1, 2 and 3 of the present submissions. This submission should also take account of the most recent paper submissions if any.
- October 6, 2015 Regulatory Artwork Services, Health Authority Updates
The dynamic environment of pharma regulatory for packaging artwork has set forth huge challenges in front of pharmaceutical and life sciences companies in terms of meeting the latest mandates. Subsequent to the rapid updates in artwork regulations, companies are facing one of the most crucial phases in their lifecycles.
- September 30, 2015 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
In the last two decades, Thailand, a country with a population of approx. 67 million has witnessed a commendable growth in healthcare sector. After Indonesia, Thailand has the largest drug market that is expected to get double by the year 2020. As per research reports, the Thai government spends 14% on healthcare, which is more than many European countries.
- September 21, 2015 Publishing & Submissions
The pharma industry operates in a dynamic and ever changing global environment governed by new regulations and mandates introduced by the Health Authorities. To get compliant with these mandates, companies are required to submit relevant information about their products to health authorities.
- September 1, 2015 Regulatory Intelligence, Regulatory Consulting
Regulatory being such a vast field of operations, often tend to create confusion for what means what. One of the most dominant services of regulatory consulting that often arrives with misapprehensions is Regulatory Intelligence (RI).
- August 5, 2015 Regulatory Affairs
Pharmaceutical companies can thrive in South Africa owing to the legislative framework for regulation of medicines and a burgeoning market for unmet medical need among sufferers of HIV/AIDS and those inflicted with other infectious diseases.
- July 28, 2015
REALIZING IDMP COMPLIANCE DEADLINE BY JULY 2016: NO TRIVIAL UNDERTAKING
There are many questions on IDMP e.g; where is the data in an organization located? Is the cleanup and alignment of current data required? How do companies organize this data for easy retrieval and submission? Does the organization have processes that can benefit from a central repository?