Analytical Services for OINDPs

OINDP development poses unique challenges, often leading to project delays and increased costs. Solvias stands out as your ideal partner to navigate these complexities. Leveraging our expertise in E&L, solid state characterization, biopharmaceuticals, and OINDP services, we offer end-to-end analytical support across the entire OINDP portfolio with one overarching goal: to expedite the journey of your products to market. Solvias provides expert support across the entire OINDP development cycle on a wide range of products.

Solvias Advantages

Accelerated Turnaround Time

The success of our customers is closely tied to time-to-market. We actively collaborate throughout the product development phase to design analytical testing plans that conform to regulatory standards, maintain the highest safety and quality benchmarks, and expedite product launches.

Our Technology

Solvias boasts impactors (NGI) and dosage unit sampling apparatus (DUSA) for inhaler performance assessment. Our automated systems (Vertus and DecaVertus) ensure reproducible testing outcomes, and our spray measurement systems (Sprayview and Spraytec) meet rigorous regulatory standards.

Regulatory Expertise

With vast experience in the inhalation sector, our team provides regulatory guidance to navigate the complex landscape of OINDP development. Our services are designed to meet FDA/EMA GMP requirements, supporting you through every step, from drug characterization to bioequivalence studies.

One-Stop Analytical Solution

Our services span from early-stage formulation analysis and device selection to full-scale analytical CMC programs, including stability, bioequivalence, and comparability studies, culminating in the pivotal commercial batch release.
- Method development and optimization
- Method validation, qualification and transfer
- Drug substance properties and forced degradation studies, solubility determination
- Stability, release and QC testing
- In vitro bioequivalence tests for generic products
- In-use studies
- Drug product characterization studies
- Aerodynamic particle size distribution by cascade impactor
- Delivered dose uniformity
- Spray Pattern
- Plume Geometry
- Droplet size distribution

The mastermind behind our OINDP capabilities

Contract Pharma recently interviewed Solvias’ team lead for drug delivery and physical characterization services, Yannick Baschung, PhD, who discussed the company’s OINDP capabilities, plans for future growth, as well as broader trends driving the OINDP market forward.

Customer Testimonial

Solvias’ expertise with testing of inhalation products has been essential to complete our product development and compile regulatory dossiers for submission in different territories.The drug delivery and physical characterization team provided outstanding support to fine tune analytical methods, perform product specific characterization studies and to complete in-vitro BE studies required for product filing at the US FDA.Their proactive support in problem solving, the flexibility and the quick reaction time, as well the effective project management have been key to making our complex developments smoother.Solvias' modern infrastructure and high-level GMP standard allowed to successfully pass regulatory inspections related to our products.
Dr. Clarissa Gobetti
Chief Scientific Officer at Phargentis

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Bring your innovation to its destination

Alongside our OINDP capabilities, we offer a wide array of analytical solutions for drug products and delivery devices, including solid state development, extractables & leachables analysis, and biopharmaceutical studies. Choose Solvias for comprehensive support and expertise in bringing your products to market with confidence. Get in touch with us today to explore how we can support your goals. Whether you're seeking advice, have a project in mind, or need insights tailored to your challenges, our team is here to listen and assist.