Biologic Regulatory Affairs

Abzena provides expert biologics regulatory affairs support, offering phase-appropriate validation, process characterization, and guidance for global submissions.

Streamlining your program from early development to commercial, we deliver biologics regulatory affairs guidance and regulatory packages tailored to you and your molecule.

Ensuring compliance and supporting a robust regulatory strategy, we develop phase-appropriate qualification, characterization, and analytical method validation approaches suited to your stage of product development and assist in preparing global filings.

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Phase Appropriate Validation

We offer consolidated phase-appropriate validation packages with fit-for-purpose methods and robust de novo assays that withstand regulatory scrutiny within biologics regulatory affairs programs.

Ensuring conformance with ICH Q2(R2), our scientists maintain cGMP compliance and high efficiency without compromising product quality or patient safety.

With decades of regulatory experience, we provide the best strategy for your molecule at any stage. Our team supports all your regulatory needs.

Process Characterization

Ensuring the robustness and repeatability of your process and consistent product quality, we use design of experiment (DOE) studies to fully characterize and document your process in support of successful biologics regulatory affairs submissions.

Saving time and supporting scalability, we focus on quality excellence while designing and delivering tailored solutions with patient safety as a priority.

Our team has extensive experience and capability to assess your process requirements prospectively, developing protocols and regulatory strategies tailored to your molecule and intended function.

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Analytical Methods: Ensuring Compliance Throughout

We follow ICH Q2(R2) guidelines for method validation, delivering robust programs that meet your requirements and support biologics regulatory affairs expectations.

Adaptable to your needs and standards, our analytical teams integrate directly into your project, providing rapid access to data.

Collaboration across analytical, process, and formulation teams ensures the development and validation of strong phase-appropriate methods.

Helping you meet regulatory and quality requirements, our experts provide guidance and design; execute; and document analytical method development, qualification, and validation programs to support even your most complex molecules.

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Analytical Method Development & Validation

Your product development program will be accelerated by leveraging our expansive in-house capabilities, technologies, and knowledge to deliver methods tailored to your molecule of interest.

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Technology Transfer

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Biologic Regulatory Affairs FAQs

What are biologics regulatory affairs?

Biologics regulatory affairs ensure biologic programs meet global regulatory expectations from early development through commercial approval.

How does Abzena support biologics regulatory affairs?

Abzena provides phase-appropriate regulatory guidance, method validation, and documentation to support global filings for biologic products.

What validation approaches are used in regulatory programs?

Our teams follow ICH Q2(R2) and apply phase-appropriate validation with fit-for-purpose methods and de novo assays.

How does process characterization support regulatory submissions?

Process characterization defines critical parameters and supports compliant documentation, strengthening biologics regulatory affairs submissions.

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