Regulatory Affairs and Quality Assurance Services

Clinical trial Quality Assurance (QA) and Regulatory Affairs (RA) are two complementary processes that are essential for ensuring the safety of participants, the integrity of data, and compliance with legal and ethical standards.

Versiti Clinical Trial Services offers therapeutic developers the experience and streamlined workflow to smoothly navigate complex regulations and ensure compliance. Our team is well-versed in advising on regulatory strategies, optimizing global filings, and enhancing submission quality through expert scientific writing.

Quality Assurance focuses on ensuring that clinical trials are conducted according to established protocols, Good Clinical Practice (GCP), and regulatory requirements. Key responsibilities include:

• Developing and maintaining quality systems (e.g., SOPs, training programs)
• Conducting audits of trial sites, data, and processes to ensure compliance
• Identifying and mitigating risks to trial integrity and participant safety
• Ensuring data integrity by verifying that data is accurate, complete, and verifiable
• Optimizing clinical trials through corrective and preventive actions (CAPA)

Our dedicated experts are here to guide you through the Quality Assurance process to ensure your clinical trial is conducted ethically and is scientifically sound.

Regulatory Affairs ensures that clinical trials comply with all applicable laws and regulations throughout the trial lifecycle. Key responsibilities include:

• Preparing and submitting regulatory documents (such as INDs, CTAs, MAAs, and more)
• Liaising with regulatory agencies like the FDA, EMA, and others
• Ensuring timely approvals for trial initiation and amendments
• Monitoring regulatory compliance throughout the trial
• Reporting adverse events and safety updates to authorities
• Maintaining documentation for inspections and audits, and more

Set your clinical trial and resulting data up for product approval with Regulatory Affairs services managing legal and ethical adherence at every step.  

Versiti’s accredited IRB services through Salus IRB and Pearl IRB safeguard ethical oversight and trial integrity, helping developers focus on the efficient delivery of innovative therapies to patients.