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Navigating the Regulatory Maze: How PSC Biotech Lights the Way

Regulatory affairs (RA) is a profession in the life science industry that involves checking whether a business is following official rules or laws regarding the safety and efficacy of products. Regulatory affairs professionals supervise the developing, testing,...

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The Secret to Writing Successful Grant Proposals

The Secret to Writing Successful Grant Proposals

Grant writing aims to prepare and submit a proposal to request funding from a grant-making organization, such as a government agency, private foundation, or corporation. Grant writing involves researching potential funders, understanding their priorities and...

Benefit- Risk Assessment for Regulatory process 

Benefit- Risk Assessment for Regulatory process 

Benefit-risk assessment is critical to the regulatory review process for life science companies and healthcare products, including drugs, biologics, and medical devices, before it is approved for use by regulatory agencies such as the Food and Drug Administration...

Grant Writing For Regulatory Processes – Whitepaper

Grant Writing For Regulatory Processes – Whitepaper

Grant writing is preparing and submitting proposals to secure funding from grant-making organizations such as government agencies, foundations, and corporations. Grant funding can be a critical source of revenue for non-profit organizations, academic institutions, and...

Annual Submissions for US in regulatory processes 

Annual Submissions for US in regulatory processes 

Annual submissions to regulatory agencies in the US are required to maintain a product’s quality, safety, and efficacy throughout its lifecycle. These include the Annual Product Quality Reviews, Annual Safety Report, and others, each with different requirements based on the impact of changes made.