Supplements/Biologics
The supplement industry includes anything from dietary supplements to sports nutrition promoting anything from hair growth, better memory, allergy relief to increase in muscle mass, higher energy levels and endurance, etc.
With the increased attention surrounding the supplement industry, there is greater activity and scrutiny from industry regulators. As more manufacturers need to abide by these regulations, the more need will exist be for advice, recommendations and solutions for possible challenges. ComplyFDA Inc. provides just that. We have the tools that can help you stay on top of what is expected and the answers on how to proceed when you run into roadblocks.
Biologics or biological products are the result of biomedical research and provide cutting-edge treatments for many medical conditions and illnesses that have no other treatments available.
These biologics often offer relief when nothing else works and may be combined with pharmaceuticals and/or medical devices. As more autoimmune diseases make their presence, the demand for biologics will only increase making the market very competitive. Give yourself the advantage by knowing the risks upfront and planning for any unforeseen obstacles that could cause delays in manufacturing. We provide that advantage. Our tools offer the requirements for the processing of tissue and for the development and manufacture of dietary supplements.
- Insider Intelligence Reports – A rolling 24 month trend in of dietary supplements and biologics regulatory activity and providing insight into areas of regulatory compliance risk. Included in the reports are active links to all dietary supplements and biologics regulations and dietary supplements and biologics warning letters for the 24 month report period.
- Dashboard Visualizations –Standard and/or custom visual dashboards providing detailed trends and information of all dietary supplements and biologics activity for all or part of the time period from 2012 through present. Visualizations are used to enhance management review, organizational collaboration, risk management, audit preparation and many other value-added activities.
- Quality Process Assessments– Objective, data-based assessments utilizing validated Quality Management System best practices to deliver detailed improvement recommendations and strategic plans. Results of assessments also provide valuable data related to Quality Management Maturity improvement opportunities.
Biologics/Dietary Supplements Insider Intelligence Quarterly
$139.99
Description
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This quarterly newsletter provides over 11 charts and graphs providing clear graphical data highlighting current regulatory trends for biologics and dietary supplements. An executive summary provides a synopsis of all data presented in the newsletter and significant changes in regulatory trends. Current Good Manufacturing Practices, Packaging and Clinical categories are successively drilled down to identify the top 8 citations for supplements. Key biologic and supplements regulatory subparts are identified through charts and graphs. Active links to all warning letters for the 2 yr time period reported are provided as well as links to FDA regulations for easy reference without the need to navigate the FDA website Among the many uses, newsletters are used to objectively evaluate risk, prioritize audit observations and corrective actions, prepare for internal audits and as training tools in addition to defining regulatory.



