Emma has over 25 years experience in the pharmaceutical industry, including 20 years in Regulatory Affairs. With a background in chemistry, and positions in Quality Control and Quality Assurance, Emma provides a comprehensive approach to the Chemistry, Manufacturing, and Control (CMC) requirements of product applications. Emma established and has been president of the regulatory consulting firm CMC Support Services, Inc. (CMC Support) since 2003. Recently, she has joined Pharma Consulting Solutions to provide global Regulatory, Quality and CMC support for our clients. For the past seven years she has provided hands-on expertise and assisted client companies in defining and coordinating their product development work, drafting and compiling their ANDA, NDA and Supplement submissions, providing support with Annual Reports, GMP audits and other compliance activities, and helping companies in their transition from traditional to CTD and eCTD submissions.

During her career Emma has held position with Key Pharmaceuticals, Schering – Plough (now Merck), SmithKline Beecham (now GlaxoSmithKline) and Elan Corporation. Additionally, through her consulting activities, Emma has also worked with small and virtual companies helping them establish GMP infrastructures, identify and work with contract manufacturing, packaging and QC facilities and support product development. Her expertise includes immediate release and modified/controlled release solid oral dosage forms and transdermal products (extended release films). Emma now looks forward to being able to provide more complete regulatory and compliance support (labeling, advertisement, medical affairs) to client companies through Pharma Consulting Solutions.