Remediation Strategy & Response

Remediation is one of an integral parts within the global regulatory life cycle. We help Biologic & drug manufacturing companies to resolve any and all kinds of complex regulatory challenges including remediation. With years of experience, we have developed a proven remediation strategy and response for several types of warning letters, observations, and consent decrees.

Our Services

Consulting

Consulting

Comprehensive Audits Remediation Plan Development & Implementation

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FDA Warning Letter Management

FDA Warning Letter Management

With our regulatory compliance team, you can develop a full proof documentation…

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Oversight Services

Oversight Services

We provide expert oversight to help you assess and rectify compliance issues.…

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21 CFR Part 11 Compliance

21 CFR Part 11 Compliance

Our experts evaluate and enhance your systems and processes to ensure drug…

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21 CFR Part 210 and 211 Compliance

21 CFR Part 210 and 211 Compliance

We assist in identifying and resolving non-compliance issues related to the current…

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Regulatory Response Planning

Regulatory Response Planning

Our team helps you plan and implement effective responses to regulatory agencies,…

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Remediation Strategy Development

Remediation Strategy Development

We work with you to create a tailored remediation strategy to address…

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Compliance Audits and Inspections

Compliance Audits and Inspections

We help your organization get ready for regulatory audits and inspections to…

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21 CFR Part 601 (BLA)

21 CFR Part 601 (BLA)

We at Elexes help Biologics companies to identify and resolve any compliance…

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Manufacturing Support

Manufacturing Support

Re-validation of Existing Equipment & Processes Remediation of System Deficiencies Related to,…

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Regulatory Action
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Regulatory Action

483 Response & Remediation Warning Letter Response & Remediation Consent Decree Response…

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Remediation strategic consulting

Irrespective of what you are looking for - corporate needs analysis, corporate growth or transformation strategy or due diligence, Elexes’ team of experts offer expertise in all kinds of services. Our remediation strategy extends to portfolio management, mergers & acquisition and staffing support from a regulatory, quality and compliance perspective.

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Client Testimonials

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