Carrie Colella Lachman Consultants

Carrie Colella is a Senior Director at Lachman Consultants whose 30+ years of pharmaceutical expertise includes Compliance and Quality Systems audits, training development, and project; management. She is well-versed in US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), and Medicines and Healthcare products Regulatory Agency (MHRA) requirements, as well as EU Medical Device Regulations, and ISO standards. Ms. Colella is proficient in GMP and GLP regulations and is experienced with GCP clinical trials. She has managed and directed complex compliance projects and continuous improvement initiatives and has led cross-functional teams from conception to operation. Her expertise includes medical device, combination products, and OTC products (inclusive of topical dosage forms.