Product Development Services Offered
Our product development services manage inhalation programs from early feasibility through clinical supply and commercialization with structured technical governance. We perform API pre-formulation, particle engineering, carrier compatibility, device prototyping, aerosol performance optimization, and DOE-driven process characterization to define critical quality attributes and operational ranges. Stability studies identify shelf-life drivers while human factors testing guides device ergonomics and labeling. During scale-up process engineers validate manufacturing steps, optimize equipment selection, and confirm aerosol performance across scales. We deliver clinical trial material with full batch records, analytical transfers, stability summaries, and regulatory support to facilitate IND/CTA and marketing submissions and commercial launch readiness.
List Of Options
What is the first step in your product development process?
We begin with a detailed technical assessment, reviewing your API profile, intended dosage form, and target device. This helps us design a development roadmap covering feasibility, timelines, and cost estimates.
Can you develop both formulation and device together?
Yes. Our inhalation-first approach ensures the powder formulation and inhaler device are developed in tandem for optimal performance and regulatory compliance.
How do you ensure particle size consistency?
We use advanced micronization and spray-drying techniques with in-process monitoring and tight specification controls to achieve consistent aerodynamic particle size distribution (APSD).
What kind of devices can you prototype?
We can design and test single-dose, multi-dose, capsule-based, and reservoir DPIs, adapting ergonomics for pediatric, geriatric, or general patient populations.
Do you follow regulatory guidelines during development?
Yes. All development work aligns with ICH, USP/Ph. Eur. requirements, and region-specific inhalation guidelines to streamline IND/CTA submissions.
How do you optimize aerosol performance?
We conduct iterative in-vitro testing using cascade impactors, next-generation impactors, and dose uniformity testing, adjusting formulation and device parameters to meet performance targets.
Can you handle clinical trial material production?
Absolutely. We produce clinical supplies under GMP conditions, with complete batch records, stability data, and regulatory documentation.
