At DArcy Compliance Consulting, our business is helping our clients to become compliant and to live compliant on an ongoing basis (i.e. not just at inspection time). At its most basic level, this is about ensuring Start-Up companies, seeking their first marketing application, are Inspection Ready which means the processes, systems and requirements expected by the Regulators are visible, demonstrable and operating (SOPs, Training, Vendors, Oversight, Audits etc.).
Regulators provide guidelines to sponsor companies on how they expect to see drugs developed. Ultimately they want to see evidence of patient safety, data integrity and development of better quality products. Sponsor companies interpret these guidelines into their own SOPs, which are then rolled out across the organization as part of training. SOPs are the backbone of drug development and an integral part of a company’s quality system. Being compliant to the Regulations is therefore critical for companies to experience successful Inspections.
Compliant Cultures are Inspection-Ready Cultures
However there is also the Business driver for Compliance. Compliance is about alignment to your well written processes and procedures. Good quality SOPs drive alignment. If individuals across the organization follow good SOPs, it drives consistency across the organization which reduces errors and minimizes potential for rework. Consistency over a long period of time drives performance. This is why at DArcy, we believe Compliance is an essential enabler of Enhanced Business Performance.
Early Stage Programs
For early stage programs, pre IND or earlier where quality matters, DArcy Compliance Consulting can:
- Conduct Quality assessments to determine how conducive your organization is to high quality research
- Create processes and procedures to drive consistency, repeatability and reduce the potential for errors in experiments.
We have worked with early stage companies who have embraced quality knowing that the investment in time and effort at this early stage will yield multiple benefits, particularly in the months prior to the filing date, as their candidates progress through the clinic to filing and approval. See a case study in conducting a Research Institute Quality Gap assessment.
The focus of much of DArcy’s work is Clinical Quality Assurance (CQA). To a large extent, we work with Clinical Operations to ensure the processes in place are compliant to ICH guidelines and if gaps exist, these can be addressed in a timely manner. The update to ICH E6 requirements (ICH E6 R2) has had a major impact on how companies oversee clinical research. Alignment to ICH E6 (R2) is therefore a key part of our clinical work. To review Clinical programs, we use simple assessment frameworks to examine the clinical operations processes and identify gaps. See more about SOPs, Training and Vendor Audits and Management.
Start-Ups are often entirely reliant on Contract Development Manufacturing Organizations (CDMOs) to develop and deliver the essential ingredients for their product. We help Start-Ups to ensure their chosen vendor(s) are fit for purpose and have the requirements in place to meet regulatory obligations. Ultimately we want to ensure that the chain of custody of investigational product exists from manufacture through to the clinical site, subject and return. We do this by conducting GMP Audits, review of Quality Technical Agreements (QTAs), review of process and conducting interviews with CMO client leads to determine robustness and security of processes for development and transfer of drug substance/ drug product. See Manufacturing Gap Assessment.
DArcy Compliance Consulting also supports Start-Up clients in select corporate compliance activities. While we are not Attorneys and do not provide Legal Advice,for early stage clients, we have created policies, procedures and training to cover activities such as Fee for Service arrangements, Interactions with HCPs, Publications and Reporting. See a case study in Clinical Compliance Gap Assessment.