As many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key…
Freyr SUBMIT PRO September 16, 2021
Freyr SUBMIT PRO May 7, 2021On-time Regulatory submission is the key to achieve quick time-to-market. But, with a lack of planning, the industry could face a lot of…
Freyr iREADY May 5, 2021As we all know, each country has its own set of cosmetic regulations that manufacturers must adhere to.
Regulatory Submission March 18, 2021Under the Classification, Labeling and Packaging of substances and mixtures (CLP) regulation, Chemical companies, who wish to place hazardous…
Freyr SPL - SPM November 18, 2020Structured Product Labeling (SPL) and Structure Product Monograph (SPM) are the mandatory document mark-up standards for the submission of label…
Freyr SUBMIT PRO November 28, 2019Drug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety…
Regulatory Software Services December 27, 2018The life sciences industry is ever-changing and evolving. It’s the same in the year 2018.
RIMS November 16, 2017As popularly known, IDMP (Identification of Medicinal Products) can be defined as a set of common global standards and technical specifications of…
Freyr LABEL 360 August 1, 2017It’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose…
Regulatory Software Services June 16, 2016Times when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for…
RIMS June 14, 2016IDMP has continued to be a hot topic in the pharma regulatory industry lately. It was expected that, in less than a month, EMA (European Medicines…
Medical Writing May 26, 2016In a general scenario, it is important to share the clinical trial analysis to increase the scope of further research and transparency in the flow…