Our mission is simple: We partner with pharmaceutical, biologic and medical device companies to help them bring products to market.
Drawing on an elite, hand-picked network of contract consultants – all of whom we know through firsthand experience – we provide flexible, expert services in five areas: Regulatory Affairs, Quality, NonClinical, Clinical and CMC.
We work with client companies to ensure they comply with all rules and regulations related to drug and product submission and approval. This includes advising on regulations and process, coordinating and preparing submissions, and acting as primary go-between with the FDA and other agencies.
Quality, safety and efficacy are the key elements in a quality assurance process. Here we support and advise clients in the three intertwined areas of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
Our consultants partner with client companies during the nonclinical phase as they determine a drug or product’s potential efficacy and final safety profile. This nonclinical phase may involve developing and planning both in vitro and in vivo studies; data analysis; report presentation and a range of medical writing as needed.
We support client companies throughout the clinical phase, as they move to using human subjects to generate efficacy and safety data for their drugs and products. This may include program and trial management, data management, clinical medical writing, clinical safety and more.
Chemistry, Manufacturing and Controls (CMC)
We work with client companies to optimize the process by which chemicals are made – from lab, to clinic, to market. We collaborate regarding the nature of the drug substance and drug product, as well as the manufacturing process, all while establishing solubility and stability controls as the drugs are developed in their various forms.
For a detailed list of our services, please download our printable PDF