Plastics are the products of human innovation, and they are stable, durable, lightweight, and most importantly, inexpensive. They are a type of polymer, composed of a chain of polymers. The life we currently live is not possible without these amazing polymers. Unfortunately, our appetite for plastic shows no sign of back-pedal.
- April 19, 2022 Chemicals, Regulatory Artwork Services, Regulatory Affairs, Regulatory Labeling
- April 19, 2022 Regulatory Affairs, Regulatory Software & Services
Life science companies face massive challenges while constantly staying ahead of dynamic Health Authority (HA) updates. In addition, it requires multiple recurring and time-consuming processes. The traditional exercises are cumbersome and laborious, proving that Regulatory operations are costly, complicated, and slow. The ever-changing sphere of HA regulations makes it arduous to keep track and adapt at the same pace.
- April 11, 2022 Food and Food Supplements, Regulatory Affairs, Regulatory Labeling
The Food Safety and Standards Authority of India (FSSAI) has divided the ‘Food Safety and Standards (Packaging and Labeling) Regulations, 2011’ into two (02) separate regulations: Food Safety and Standards (Packaging) Regulations, 2018 and Food Safety and Standards (Labeling and Display) Regulations.
- April 4, 2022 Medical and Scientific Communication, Regulatory Medical Writing
With an increasing number of new drug applications and clinical studies conducted to substantiate the efficacy and safety of new molecules, it becomes critical for pharmaceutical organizations to disseminate scientific information to the target audience via publication in a renowned scientific journal.
- April 4, 2022 Pharmaceuticals, Regulatory Labeling
Effective communication has always ensured the safety and quality of care for patients. Over the years, there remains an unmet requirement of providing label translations to individuals who are not fluent in English. The demand for product labels in multiple regional languages has grown exponentially as pharmaceutical manufacturers intend to drive the change towards localization and better communication.
- April 4, 2022 Compliance, Audit and Validation
Do you know? One can save up to a million in the coming three (03) years by introducing Computer Software Assurance (CSA) in place of the existing Computer system validation (CSV) model!
Over the years, pharmaceutical organizations have incorporated CSV, a risk-based validation approach to ensure computer operating systems are at par with Regulatory requirements.
The ever-increasing demand for various channels to share information and engage with customers poses numerous challenges in the pharmaceutical industry. Such engagement comes with risks, particularly in the advertising domain. To ensure accurate and good practice, Health Canada regulates the advertising or promotional material before its dissemination in Canada.
- March 31, 2022 Pharmaceuticals, Regulatory Affairs, Market Access
On February 09, 2022, the European Medicines Agency (EMA) commenced the establishment of a Coordination Centre for Data Analysis and Real-World Integration Network (DARWIN EU®). It is the first step towards integrating Real-World Evidence (RWE) into assessing medicines across the European Union (EU).
- March 31, 2022 Pharmaceuticals, Cosmetics Regulatory Services, Regulatory Affairs
Sunscreen is an important component of an effective sun protection regime. They must be safe, effective, and of good quality. For this reason, the TGA regulates sunscreens as therapeutic goods in Australia under the Therapeutic Goods Act 1989. The Australian Regulatory Guidelines for Sunscreens (ARGS) describe the Regulatory requirements and standards for sunscreens and their ingredients.
- March 31, 2022 Pharmaceuticals, Regulatory Affairs
Medsafe, aka the New Zealand Medicines and Medical Devices Safety Authority, undertakes the regulation of therapeutic products in New Zealand. The Agency is a business unit of the Ministry of Health. It follows several legislations for regulating therapeutic products, the major ones being the Medicines Act of 1981 and Medicines Regulations.