DArcy Consulting is a niche Quality & Compliance consulting company with a focus on Start Ups. We work exclusively with Life Science Start ups and help them put in place the quality and compliance requirements for successful filing and launch. Our clients are gene therapy companies, cell therapy clients and typically clients that operate in the rare disease space. We do not work with large Pharma or large Biotech simply because our knowledge, experience and passion is helping Start Ups grow successfully. We are a small company and our size over the years has proven to be a major strength. All or our clients are small companies - it simply works for us to be small, nimble and focused.
We typically work with companies that are planning pre IND activities, embarking on their first clinical trial or planning for filing and subsequent inspection. We help companies:
A. Understand the regulatory requirements and expectations around drug development
B. Put in place the processes and supporting SOPs (including work instructions and templates) to support their technical operations and clinical trials – Yes we write SOPs.
C. Provide training on Quality and Compliance requirements (GCP, GMP, Quality etc.)
D. Support companies in conducting vendors (GMP & GCP) as well as site audits
E. Conduct Inspection readiness activities (including mock inspections)
We also have started to work extensively in the Corporate and Commercial Compliance space where we have helped our clients create the corporate policies and procedures required for marketed products. This includes development of policies and SOPs and e-learning on policies.
Please contact us at your convenience for an initial consultation. We look forward to hearing from you.
Call Today: (610) 241-6983
Quality & Compliance Solutions for the Life Science Industry