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QUALITY & ANALYTICAL SERVICES

Regulatory Support

Align your product development and related deliverables with regulatory agency expectations. 

ProBioGen provides you with regulatory guidance and support to prepare for high-quality, regulatory applications and the timely granting of approvals. Do it right the first time. 

IN A NUTSHELL

Regulatory Guidance to Guarantee Compliance at the Highest Level

Navigating the complexities of regulatory requirements is crucial for successful CDMO projects. Our team provides expert regulatory guidance and strategies to ensure compliance with EMA and US-FDA standards. We optimize process and product development programs in line with current agency expectations, incorporating principles like quality by design and quality risk management. We foster regulatory awareness and compliance at every stage by proactively embedding regulatory knowledge across our organization. Trust us to streamline your path to regulatory approval. 
Regulatory Support
HOW WE WORK

Providing feedback and information on changing requirements during the development process

Offering early input on process and product development protocols and reports

Providing guidance for an integrated control strategy and specification setting

Giving quality by design/quality risk management guidance for processes and analytical techniques

Preparing you for and supporting you during agency hearings with sound scientific advice

Developing a strategy for comparability/biosimilarity assessment [for biosimilars] 

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Our Promise To You

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Mitigate Risks As Early as Possible

 

  • By ensuring regulatory requirements are already fulfilled during development activities

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Guarantee Smooth Regulatory Processes 
  • By following regulatory principles like quality by design/quality risk management for processes and analytical techniques 

 

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Level Ground with Expert Guidance

 

  • Meet agencies on a level playing field by relying on our expertise for regulatory applications, agency hearings, and scientific advice 

Elevate Your Candidate With The Right CDMO

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