CHEMISTRY PLAYBOOK

The Chemistry Playbook is a partnership between CML and other U.S. affiliates, formed to provide customers with end-to-end solutions and create efficiencies within a single supplier network. The Playbook streamlines product development through integrated communication between experts representing key pillars in the drug development process including API, Formulation, and CMC/Regulatory Consulting.
Chemistry Playbook members include:

Cambridge Major Laboratories – API Development

Cambridge Major Laboratories (CML) is a leading global chemistry outsourcing partner to the pharmaceutical and biotechnology industries. CML produces pharmaceutical intermediates and Active Pharmaceutical Ingredients (API), from early preclinical development to commercial manufacture. Operating from FDA inspected facilities in the U.S. and Europe, CML is organized along five key Centers of Excellence including Process Chemistry, GMP Manufacturing, Solid State Chemistry, Analytical Services, and Quality/Regulatory Compliance.

Xcelience – Formulation

Xcelience is a contract research organization providing formulation development, preformulation, analytical, and clinical trial manufacturing to a global client base since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Xcelience's unique corporate structure creates project teams that work intensively with each client, bringing an extension of their own organization into the Xcelience lab.

Beckloff Associates - CMC Consulting/Regulatory Compliance

A Cardinal Health company, Beckloff Associates provides a wide range of consulting services required to obtain marketing approval for drugs, biologics, and medical devices for the U.S., Canadian and European markets. Beckloff strives to help biotechnology, pharmaceutical, and medical device customers increase the financial return on their research investments through the design and implementation of efficient global scientific and regulatory strategies.

Micron Technologies

Micron Technologies is a leading international provider of particle size reduction, engineering, and analytical contract services. Services include; pharmaceutical contract micronization, milling and analytical services.

Resources

• Partner with Chemistry Playbook