We provide complete support for Pharma Regulatory services with our expert Pharma Regulatory Affairs consulting services for global markets, particularly in the EU and US.
Zenovel has a highly experienced team of experts who have a complete understanding of the complete requirements of Pharma Regulatory affairs throughout the drug life cycle. Our experts have experience in directly corresponding with Pharma regulatory authorities for various segments.
As regulations continue to tighten, authorities are demanding increased vigilance of the pharmaceutical supply chain and emphasizing the need for on-site audits. Manufacturers are required to conduct GMP audits of suppliers or have them conducted on their behalf by appropriately qualified and trained auditors. GMP audit identifies the risk factors that challenge the organisational critical area and further consider their significance.
Zenovel provides a wide range of audit services to clients as per their specific needs. Having conducted numerous audits, Zenovel now has a big GMP Audit Report Library with Long Validity of GMP Audit Reports.
To evaluate the system and manufacturing facility in compliance to the regulatory expectation and quality standards. To ensure the capability of the facility to manufacture quality medicine. To determine the effectiveness of the Quality system implemented and adherence to the specified quality objectives.
At Zenovel, we have been conducting Remote GMP Audits/ Virtual Audits of suppliers for our clients. In the global pandemic situation, there have been many restrictions on travelling and this makes the on-site audit difficult. With the acceptance of Remote Audit by various regulatory agencies, many of our clients have suggested performing remote audit / Virtual audit. Zenovel has well defined SOPs and systems to perform Remote Audits. So far, we have completed more than eighty Remote Audits on behalf of our clients.
Zenovel has been conducting GMP GAP audits for numerous Pharmaceutical Companies to assess their level of compliance with requirements of Desired Regulatory Agencies.
GMP GAP Audit is conducted to identify any GAP in the system and procedure to meet specific regulatory requirements and to mitigate the GAP with reasonable and logical solutions. A successful gap analysis identifies necessary changes in process, organization, and resources, and maps out a systematic approach with corrective and preventive actions for implementing solutions that effectively minimize risks to the organization.
A compliance audit is done for a comprehensive review of an organization’s adherence to specific regulatory guidelines & specifications mentioned and to evaluate the strength and thoroughness of compliance preparedness. This audit also focuses on the QMS system and any loopholes to work on. Improves the Quality system and in turn compliance to regulatory.
To evaluate and qualify the vendors for procurement of the critical supplies like API, excipients, packaging material, contract manufacturer, materials & Goods etc. This vendor qualification audit ensures the vendor reliability and quality services/products to avoid any regularity concerns.
This Audit is mainly conducted before any planned or announced regulatory inspection of the facility. This audit covers the complete 360-degree assessment approach to get ready for the regulatory audit.
