by Prakash Achaary | Apr 11, 2023 | Blog
FDA Form 483s, more commonly referred to as 483s in the pharmaceutical industry, is a nonconformance issued by the Food and Drug Administration at the close of an inspection. Feared by everyone in the industry, this type of observation can elicit panic in the...
by Prakash Achaary | Apr 6, 2023 | Blog
Gary Pekoe, Principal Medical Writer at MMS, has over 35 years of experience working professionally in the pharmaceutical industry. We’ve asked him to write an article on his mentoring experience over his career. Looking back over my career in the pharmaceutical...
by Prakash Achaary | Mar 21, 2023 | News
CANTON, Mich. (March 21, 2023) – MMS Holdings, an award-winning, data-focused CRO, announced today the addition of Dr. Philip Breitfeld and Dr. Bernhardt Zeiher to its board of scientific advisors. Both industry leaders in innovative clinical trial delivery solutions,...
by Prakash Achaary | Mar 16, 2023 | Blog
The FDA recently developed a new Manual of Policies and Procedures (MAPP) to address the challenges of Chemistry, Manufacturing and Control (CMC) readiness for products with accelerated clinical development programs. This MAPP became effective on December 7, 2022 and...
by Prakash Achaary | Mar 16, 2023 | Blog
Full or Hybrid decentralized clinical trials (DCTs) are facilitating new treatments through the advancement of clinical development in many therapeutic areas and will likely be incorporated into more trials every year. To make this transition as successful as possible...