12.05.25 -- FDA PreCheck Implementation Recommendations

The large, bulky structure of TPDs limits solubility and permeability. Enabling technologies like spray drying, hot melt extrusion, and nanomilling are key to formulating these challenging molecules.

Reimagined as an automation-first discipline, bioanalysis shifts from an Investigational New Drug (IND) bottleneck to a catalyst for innovation — helping move therapies forward.

By integrating scientific rigor, regulatory foresight, and market awareness into early-stage planning, companies can leverage a robust TPP to optimize decision-making and development.

Human/ai cooperation is at the heart of Sanofi’s Plai.qa platform, which sits within the broader Plai infrastructure. The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

Some drugs violate multiple Ro5 elements but remain developable, while some molecules adhere strictly to the Ro5, but their properties are not conducive to development.

Establishing and utilizing quality metrics is essential for the pharma industry's future success. Learn how to identify meaningful metrics and appropriately measure quality to make better business decisions.

Selecting the right GLP-1 peptide manufacturing route determines the specific impurity profile and regulatory strategy. Robust analytical methods are essential for ensuring efficacy and patient safety.

Screen-Printed Innovative Drug Technology can produce oral, transdermal, and implantable dosage forms while ensuring heterogeneous distribution of active ingredients.

See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

Thanks to patient-centric technology, patients are more empowered, making it essential to promote better adherence, improve medical benefits, and bolster market perception.

This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

Biocatalysis utilizes enzymatic synthesis to provide pure regio-, chemo-, and enantioselective compounds, compared to traditional chemical synthesis.

From early formulation to full-scale commercial production, our CDMO team delivers customized solutions for every stage of your drug development journey.

PSS hires, trains, and manages scientific personnel who perform defined scopes of work directly at client sites — fully integrated into client operations yet fully employed by Eurofins.

We offer comprehensive solutions for Dry Powder Inhalers (DPIs), encompassing all stages from initial formulation screening to clinical-scale manufacturing.