Our broad network in the pharmaceutical contract research and manufacturing space allows us to place programs with the CRO/CMO best suited to your specific needs. We partner with you to establish the best combination of cost, speed, technical and regulatory quality of work. Accela Sciences has the ability to source projects both domestically and internationally, in both small specialty laboratories as well as large integrated service providers.
We will create a development plan based on your regulatory strategy, from early technical assessment, toxicology, formulation, bioavailability and pK studies, to analytical development, scale-up, clinical and commercial manufacturing, and manage this program in the CRO/CMOs to meet your timelines and your budget.
Recent projects have included:
• Remediating a difficult formulation for a veterinary allergy product
• Developing a novel pesticide formulation with an organization in Asia
• Developing a plan utilizing best-in-class service providers which saved over $100K on scale-up to manufacturing costs for a small specialty pharmaceutical company
• Facilitating a phase III product transfer to an acquiring organization
• Remediating outdated analytical methods in response to FDA inquiries
