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A maven is a trusted expert in a particular field, who seeks to pass timely and relevant knowledge on to others in the respective field.

 

Maven E&L Ltd  Registered Company 12174225

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Services Maven E&L offer

We offer a wide range of expert services and consultancy.
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Call : +44(0) 7584 120126  Email: Admin@MavenEandL.com

Technical Risk Assessment for leachable risk

Proven and tested methodology for a full technical risk assessment of your project highlighting risks posed from leachables in your drug product, drug substance and associated manufacturing process. Allowing you to consider risk reduction strategies through guided studies and safety risk assessment

  • Arrange work programmes with partner laboratories

  • Advice on material selection

  • Control strategies to aid in Regulatory Approval

  • Work witth your toxicologist or suggest a partner for safety assessment

Authoring and Review of Work Protocols for Extractable or Leachable Studies

Maven E&L has authored hundreds of protocols for leachables or extractable study programs. Let us author or review your protocols to ensure first time success. Extractable and Leachable studies can be time consuming, difficult to plan, and costly. Let us use our experience to guide you to effective plans to deliever the information you require for a successful project delivery.

  • Bespoke Extractable Studies designed to simulate leachables in your drug product

  • Extractable studies which align with latest industry best practice

  • Cost effective leachable protocol design with tested regulatory alignment 

Authoring of Reports for Inclusion in Regulatory Sections of a CTD

Extractable or Leachable Summary Reports authored for direct inclusion into your regulatory file. Clear advice on suitable content for inclusion into your regulatory file covering major markets. 

  • Reports which capture your internal risk assessment

  • Reports to summary and report your extractable studies on container closure systems or manufacturing process materials

  • Reports covering analytical development and validation

  • Leachable Study reports and safety assessment summaries

Expert Monitoring and Review of CRO Output

Analytical laboratories (CROs) in this topic area produce specialist, highly technical output. Let us translate that output into easy to understand summaries. With many years experience in setup and monitoring of CROs, Maven E&L can monitor the output of your chosen laboratory to ensure you get the outcomes you expect and require for your project.

 

  • Ensure CRO are operating to required thresholds and standards

  • Setup regular techncial review meetings

  • Ensure on time delivery with value for money

  • Follow-up and investigation unexpected results