Risk Management Plan (RMP) Development and Maintenance

A new or updated Risk Management Plan in Pharmacovigilance may be required when there are certain distinctions to the marketing authorization. This requirement entirely depends on the nature of this variation and may not be necessary in all circumstances. Our subject matter experts and Pharmacovigilance risk benefit specialists will advise both on the need for an abridged RMP and on its content.

 

Gemini Group will partner with our clients to help determine important identified and potential risks. We will employ this approach for both detailed and abbreviated risk management plans.

Gemini Group has deep experience and know-how in writing RMPs, assessing risk benefit analysis, and conducting RMP maintenance. We are exerts in GVP Module V and can advise or perform a thorough analysis of the effectiveness of the risk minimization activities a company utilizes.

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Postmarketing Writing Services to Help You Meet Regulatory Obligations

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The Risk Management Plan (RMP) is the scientific and precise living document that accompanies a medicinal product throughout its lifecycle. In the RMP, everything about the product comes together. Safety risks are identified and updated, and all actions/events regarding efficacy and safety are analyzed and disclosed.

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We utilize our intimate knowledge of developing top notch RMP’s to guide you through the process of creating and then maintaining a superior quality RMP, that most importantly meets all of the regulatory requirements.

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Across-the-board Pharmacovigilance Expertise

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At Gemini Group, we ensure that you meet all of the requirements when developing and maintaining your RMP. We help you create your RMP to identify and characterize the risks of a medicinal product in a succinct and efficient manner. Our strategy and know-how will save you both time and money when interacting with the regulatory authorities. We will assist you in elucidating and applying postmarketing obligations that are to be included in the RMP, including, but not limited to developing or reviewing educational material and risk minimization measures (RMMs), as needed.