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 17, 2015 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
- 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?
- July 7, 2015 Regulatory Artwork Services, Regulatory Labeling
Artwork design is an essential process in the supply of a pharmaceutical product which basically ensures patient safety while reducing recall risk.
- June 16, 2015 Regulatory Affairs, Regulatory Medical Writing
A Medical writer plays a prominent role in writing various non-clinical and clinical documents related to drug approval from health authorities, in order to bring it to the market for making them accessible to the customers. Medical writer needs to produce high quality documents in a short time.
- June 10, 2015 Regulatory Consulting
Outsourcing has become an increasingly common practice in the Pharma and Biotech industry more so in the area of regulatory affairs and Pharmacovigilance.