In the highly regulated field of life sciences, accurate and well-crafted regulatory submissions are crucial for gaining approvals, ensuring compliance, and bringing innovative products to market. Technical writing plays a pivotal role in these submissions, as it requires a unique skill set to effectively communicate complex scientific and technical information to regulatory authorities. In this […]
Regulatory bodies, also known as regulatory agencies, are independent governmental bodies established to set standards for an industry and enforce those standards per legislative acts. In Life Sciences, these regulatory bodies oversee the process of production of new products such as drugs, biologics and medical devices, including regulating the research and testing process as well […]
The clinical operations (clin ops) sector of the life sciences industry has been facing some challenges recently, including finding the right staff and managing their budget effectively. Life sciences companies often operate with limited budgets and face pressure to produce results quickly. However, with the right strategies, it is possible to maximize your staffing budget […]
The life sciences sector is a rapidly growing industry that plays a crucial role in improving public health and medical research. As the industry continues to expand, companies must ensure they have effective onboarding and training strategies for new employees. Effective onboarding and training can increase productivity, reduce employee turnover, and improve job satisfaction. In […]
Tim May Promoted to Sales Director
BizcastNH interviews Cristina Muise
An FDA inspection is not a matter of if, but a when, for life sciences companies. Especially organizations manufacturing Class II or Class II devices, pharmaceuticals, and other regulated products, can expect to have FDA regularly show up for an audit. Unfortunately, not every audit goes without a hitch, and some companies might receive a […]
The life sciences industry has faced many challenges, especially in the past five years. Organizations had to adapt and find new ways to approach managing quality and compliance process to ensure product quality and consumer safety at the face of new regulations, continuous technological advancements, intense price pressures, and a global pandemic. Here are three […]
View one or all of the 4-part med device development webinar series presented by Don DeLauder and hosted by Maria “Cristina” Muise, MBA, Ph.D., MBA, Ph.D. ABOUT THE PRESENTER: The webinars are presented by Don DeLauder. Mr. DeLauder is an expert in medical device development with over 25 years of experience in the field. He also has 14 […]
GMP audit
