The TRAC team’s chemistry, manufacturing and controls (CMC) experience and know-how is second to none. The work we carry out on a daily basis spans the global marketplace and we are well-versed in working with the centralised and affiliate regulatory teams of pharmaceutical companies.
CMC is an integral part of drug development, licence applications and the on-going marketing of a medicinal product. As drug development moves from concept to commercialisation, the extent of CMC documentation required in submissions increases in parallel.
Our current team of 16 in-house regulatory affairs consultants delivers specialist CMC support to a growing client base that covers all active regulatory markets, from frontline markets (Europe, Australia, North America and Japan) to emerging markets such as Brazil, China and India.
We offer a broad range of services to support CMC activities at every stage of the product lifecycle, from compiling investigational medicinal product dossiers (IMPDs) to completing a CMC compliance gap analysis/due diligence and delivering the remediation plans.
We have experience of working with the majority of dosage forms including: solid dose (tablets, capsules, soft capsules, immediate release, modified release, effervescent tablets, lozenges), sterile products (injections, sterile powders), suspensions, inhalers, nasal sprays, suppositories, creams, ointments and patches.
Many of our global CMC projects have involved manufacturing site transfers which by their nature are often confidential, can involve multiple technical changes, and, when global markets are included, can extend over a considerable time period.
The TRAC team’s experience, extensive resource base and flexibility mean that we are able to deliver solutions that fulfill and often exceed our clients’ expectations.