Strategic regulatory support and precise bioanalysis

Strategic regulatory support and precise bioanalysis

Gain insights into our strategic regulatory support and precise bioanalysis services for regulatory compliance.

Ardena’s regulatory support and bioanalysis services expedite global product approval. Leveraging expertise in scientific writing, CMC documentation and regulatory navigation, we facilitate seamless preparation and negotiation of applications. Additionally, we provide strategic guidance and precise bioanalytical measurements tailored for nanoparticle-based formulations, ensuring regulatory success and product integrity.

Comprehensive CMC regulatory support for nanomedicines

Leveraging our in-depth expertise in scientific writing, CMC documentation requirements and regulatory processes, Ardena fast-tracks your product toward global regulatory approval. From initial scoping and compilation of quality dossiers to post-approval activities, we ensure the preparation and negotiation of your applications throughout the entire drug development process.

Nanomedicines are complex formulations that pose unique regulatory challenges due to limited guidance. As your accountable expert, Ardena provides invaluable regulatory insights and ensures compliance within your team. Our strategic advice covers specification setting, stability design, product classification and more, aiming for a seamless flow of information in quality documentation such as Module 3.

With a dossier-centric approach, we prioritize quality improvement, risk mitigation and adherence to budget and timelines. Our dedicated team stays ahead of the latest ICH, EMA, FDA and other relevant guidelines, drawing from our extensive experience in handling dossiers for complex formulations.

Advanced bioanalytical services

With over 20 years of experience measuring a wide variety of therapeutic modalities in samples from both GLP and non-GLP preclinical or clinical studies, Ardena’s bioanalytical platform ensures the timely achievement of your clinical milestones. We specialize in supporting pharmacokinetic, pharmacodynamic, drug metabolism and immunogenicity measurements.

As an integrated service within our nanomedicine manufacturing group, we are experienced in analyzing nanoparticle-based drug products with a wide variety of payloads, including small molecules, proteins, antibodies, antibody-drug conjugates and oligonucleotides.

The bioanalytical evaluation of nanoparticles can be complex, often involving multiple active drug substances, major metabolites, nanoparticle derivatives and impurities. Additionally, APIs can be measured in their total, free and bound forms.

Leveraging LC-MS/MS, ligand binding assays and an in-house flow cytometry facility, we lead the development and validation of your drug’s assays. For nanoparticles, we employ an integrated approach to evaluate all parameters comprehensively.

Related resources

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