Development

During pharmaceutical drug discovery, we explore and ask incisive questions to ensure we understand and assimilate your objectives and desired formula characteristics—which govern and inform each step of the pharmaceutical development phase.As we conduct in-depth preclinical research, analysis and screening of each active pharmaceutical ingredient (API), assessing how compounds interact with the body, we are 100% transparent with our findings. This critical process lays a foundation for optimal bioavailability, stability, solubility, safety and administration methods for FDA-compliant end-products.During this time, we select the suitable pharmaceutical excipients and other components for material suitability, plus determine the most effective composition, drug delivery system and patentability.

Within this comprehensive process, we create, evaluate and optimize the pharmaceutical manufacturing methods required to develop products end-to-end. This phase assures that the lab research translates effectively into large-scale production, maintaining formulation consistency, safety and the highest quality in accordance with regulatory compliance standards.We examine the critical quality attributes and parameters(CQAs and CPPs) and begin the pharmaceutical validation process, denoting the steps necessary to purify, synthesize and package each pharmaceutical cost-effectively and efficiently. These measures also reduce waste and minimize environmental impact—ensuring the smallest carbon footprint possible.

We conduct stability testing of pharmaceuticals to test the duration of a particular product’s efficacy, quality, potency and stability to ensure patient safety and regulatory requirements are met. We take, store and test samples at specific times and employ long term stability testing, realtime stability and accelerated stability studies [KW1] to see how a formula changes over time. Sensitivity to light, heat and humidity, plus container closure integrity and systems, are key factors examined. This information enables us to establish an accurate shelf-life and assure that each drug is FDA compliant and delivers its intended therapeutic effects.

Recurrent reviews and progressive improvements are integral components of pharmaceutical and medical device production, warranting the utmost quality of each drug to meet patients' needs, compliance and retention more favorably.Continuous improvement involves uncovering and correcting inefficiencies, time- and cost-saving initiatives, risk management and optimized procurement procedures—vital for flexing with the latest industry standards, regulations, market challenges and advancements.

DESA follows a validated and documented four-part stability testing process to consistently and accurately assess the stability of pharmaceutical products, verifying alignment with prevailing quality standards before release to market.