Carefully considering different countries regulation peculiarities and combining it with international experience, our global team of multilingual professionals will help you to maintain required quality level and prepare for interactions with regulatory authorities. Our services include Audits, Internal and Project Documents Development, Regulatory Inspection Preparation; Regulatory and Institution Review Boards/International Ethic Boards (IRB/IEB) Submissions.
Our Global Team Of Specialists
Quality Assurance and Regulatory
Audits
ZM Group specialists’ in-depth knowledge of local, national and international guidance and regulations combined with experience of trial conduct in different therapeutic areas, such as Oncology, Hepatology, Gynecology, Ophthalmology, Otolaryngology, Nephrology, Musculoskeletal, provides a solid background for the conduct of the following types of inspections:
- Vendor Audits
- ICH-GCP Compliance Audit
- Site Audits
- Study-Specific Audits
- Pharmacovigilance (PV) Systems Audit
Regulatory and IRB/IEB Submissions
Effective information exchange with health authorities and various controlling organizations is a key to a successful conduct of a trial. ZM Group is providing our clients with support in the submission and communication process during Phase I- IV Clinical Trials and Post-Marketing Studies.
- Submissions to local RA (Regulatory Authorities)
- Submissions to local/ central IRB/ IEB (Institutional Review Board/ Institutional Ethics Board)
Our specialists are also available to take up Site Management Organization (SMO) responsibilities to satisfy your project requirements.
Internal and Project Documents Development
From tracking tables to Standard Operating Procedures (SOPs), ZM Group team is ready to prepare documentation for internal company operations, as well as project-specific documents in accordance with requirements:
- SOPs (Standard Operation Procedure)
- WIs (Working Instruction)
- Checklists
- Study-Related Documents
- Regulatory Documents
Regulatory Inspection Preparation
Our specialists in preparation and successful conduct of clinical trials around the globe have a high level of expertise in quality management systems, applicable regulatory guidelines and regulations, country-specific laws, interaction with local regulatory bodies, and excellent customer service. ZM Group offers:
- Consulting Services
- Audit Preparedness Assessment
- Internal Document Assessment
- Corrective and Preventive Actions (CAPA)
- Liaison with Regulatory Authorities (RA)
