Communication Documentation Download 
Impact Pharmaceutical Services
SEPTEMBER 20, 2023
Challenge Syner-G was contracted by a US Pharmaceutical Company to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.
The FDA Law Blog
DECEMBER 12, 2022
It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop. The following Guidance documents are critical to understanding the FDA’s policy for software products: Changes to Existing Medical Software Policies. The flowchart can be downloaded here.
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Pharmaceutical Technology
FEBRUARY 8, 2023
In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.
Pharmaceutical Technology
SEPTEMBER 5, 2022
Pharmaceutical companies have also entered the social media marketing domain in compliance with governmental regulations to communicate directly with patients using covert persuasion methods such as collaboration with social media influencers. Discover the leading direct-to-consumer pharmaceutical marketing companies.
Pharmaceutical Technology
FEBRUARY 28, 2023
To learn more about how the 3M Harvest RC Chromatographic Clarifier is revolutionising biopharma production, download this specially commissioned white paper. Download to learn more. This can result in reductions in costs for our customers.” Please use the Intake form to object.
pharmaphorum
AUGUST 30, 2022
The importance of patient and public involvement and engagement (PPIE) has been well documented, but there has, to date, been a lack of practical advice on how to implement and manage meaningful processes. . The result was the EnACT (engage, acknowledge, communicate, and trust and transparency) principles, as set out in the guide: .
The FDA Law Blog
MARCH 7, 2023
If multiple people are reviewing and need to communicate changes it may be challenging to ensure all updates are incorporated. Lack of compatibility with cloud-based document sharing. It must first be downloaded, revised, and uploaded back to the system. Creation of unnecessary documents.
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