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About Us

Committed to Excellence

International Compliances Service Maven and Associates have been consulting in the pharmaceutical, biopharmaceutical, and chemical industry for over 20 years.

 

We provide our clients quality, compliance, and regulatory support throughout Europe, North America, South America, and Asia.

 

The foundation of our success is driven by the combined experience of our core associates, managing critical quality, compliance, and regulatory challenges through working with multinational large pharmaceutical, biopharmaceutical, chemical companies, small start-ups, and consulting firms within the global arena. 

 

When you choose ICS Maven as a service provider for your project, our subject matter experts integrate together with your management team and create an intangible environment which every project needs to guarantee success with sustainable outcome.

Our Core Associates:

  • Each has more than 25 years of  quality and compliance experience  

  • Have managed consent decree projects

  • Remediated warning letter observations and eliminated FDA sanctions

  • Prepared product registration files

  • Meet with regulatory agencies ( FDA)

  • Prepared sites for PAI

  • Designed QMS

  • Prepare regulatory and operational strategies

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Experience

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Range of Support:

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The scope of our activates includes but not limited to:

  • Green field projects management

  • Inspection readiness

  • Regulatory Authorities response and remediation (i.e. FDA WL, etc.)

  • Regulatory strategy & support

  • QMS design and Implementation

  • Due diligence & auditing

  • Hands on shop-floor support (deviation, OOS, CAPA mgt.)

  • Cold chain , management

  • Qualification  & Validation

Timing is a critical element of any project; consequently, speed and agility are integral features of successful project management. Our associates put great emphasis on:

  • Listening to the client

  • Conducting in-depth assessment of issues

  • Planning the course of action in detail

  • Implementing the action first time right

  • Remaining mindful of the unexpected events and/or  clients’ needs for change of direction and priorities

  • We are always prepared to overcome unforeseen obstacles and meet the deadlines

On Time and Within Budget

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