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Regulatory Compliance Gmp Gap Assessment Aveta Audits & Inspection Preparation |
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Compliance Regulatory Compliance Aveta engages the regulatory affairs function of healthcare companies from the initial drug filing to pre-approval inspections for market launch and beyond. Aveta understands the nuances of the international regulatory environment from pre-clinical development to post market surveillance for pharmaceuticals, biotech, oncology & medical devices. Aveta’s regulatory affairs services include advising on regulatory strategy & planning, scientific consultancy & data assessment, preparation, submission & maintenance of clinical trial and marketing authorization applications including eCTD. Aveta Regulatory Offerings Filings & Submissions
Product Licensing Pharmaceutical products for the European Union can only be commercialized after Marketing Authorization (MA) has been granted by a Competent Authority. AVETA is able to assist in preparing for the Competent Authority with our comprehensive approach that includes:
Qualified Person All medicinal products distributed within the European Union, whether manufactured inside the community or imported from third countries must receive a Qualified Person release inside the EU. AVETA is able to provide full QP support services. Remediation & Sustained Compliance Our Regulatory Compliance Group can assist clients in responding to Agency inquiries and developing corrective action plans from a wide range of regulatory actions to ensure sustained compliance with domestic and foreign regulatory requirements. Aveta Compliance Offerings:
Aveta Regulatory & Compliance Expertise:
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Gmp Gap Assessment Aveta is adept at finding and closing compliance gaps in your Quality / GMP Operations program. Our systematic approach based on the USFDA’s QSR coupled with our extensive industry & process knowledge thoroughly examines the procedures, processes and practices in your organization or your supplier’s. Our assessments are performed by professionals who understand worldwide regulatory requirements, track inspection standards and provide highest quality review for regulatory compliance. The USFDA’s emerging “cGMPs for the 21st Century” and the ICH guidelines have created a regulatory environment that is extremely complex. Aveta not only has the experience with the new regulations, we also have the ability to integrate those requirements into your existing processes & procedures to enable your Quality & Operations groups to achieve Best Practices which almost always translate into significant cost savings in reduced cycle times, more robust, but fewer quality checks and higher yields. Also with the new USFDA Inspectorate, inspections have become much more rigorous and what used to be noted as minor observations are now being used to point back to the Quality Systems with major observations at a systemic level. Aveta’s assists our clients in Inspection preparedness to eliminate or reduce many of the Quality System gaps that translate into Inspection observations. Though a gap assessment may be focused on a specific area or areas, a typical cGMP Compliance Gap Assessment that covers the full regulatory compliance scope comes in two phases: Phase 1: Inclusive of the following systems / areas of inspection:
Phase 2: Implementation plan for gap closure based on gaps identified in the audit. The scope for this phase will be determined after gap analysis of quality systems. [ †Top ]
Aveta Audits & Inspection Preparation Because of the recent changes in the USFDA & EMEA regulatory environment with GMPs for the 21st Century, ICH guidelines, and Risk Based process development, the new international Inspectorates have high expectations that a company will have a robust scientific based characterization of their processes that has both measured and mitigated the risks to that process and the public. This is done within the context of a QSR Inspection that anticipates that the Quality Systems will be robust, integrated and fully embedded in the day to day running of the company’s operations. The penalties for inadequate Quality Systems and non-compliant processes are putting both products and companies at risk. Aveta’s experts help to identify compliance risks with a methodology to reduce or eliminate the risks going forward. Aveta’s Auditing Services fall into three basic categories: Internal Audits, External Audits and Regulatory Inspections. Regardless of the type of Audit, Aveta’s team of experts can assist in the development of programs, determination of metrics, training on specifics and rapid closure of any gaps. Aveta’s systematic approach thoroughly examines the procedures and practices in your own organization or that of a supplier. Internal Audits: Aveta recognizes that a robust Internal Audit program is the best defense in preparing for an international inspection, maintaining sustainable compliance and having an efficient, cost effective, manufacturing environment. Aveta’s experts understand the challenges with developing robust procedures and putting in place a strong team of internal auditors. We begin by evaluating the current systems, then working directly with management, operations and your Internal Audit team to put in place a world class Internal Audit program to identify and remediate compliance and process problems before they become inspection observations. Internal Audit program assistance in:
External Audits: Aveta has deep experience at auditing Vendors / Suppliers and performing Due Diligence with an eye for compliance to ensure that problems are identified for potential remediation or contract negotiation. Typical services include auditing of Contract Research & Manufacturing Organizations; API, Excipient & Raw Material / Component Suppliers. Regulatory Audits (Inspections): Aveta has an extremely thorough approach to Inspection preparedness that includes performing Mock Regulatory Inspections and Due Diligence Audits for organizations planning for FDA, EMEA or other regulatory inspection. Preparation includes planning with and training personnel in how to prepare documents, interact with inspectors and a successful approach in fielding questions to avoid getting into trouble. Inspection preparation includes case studies in how to / not to host inspectors for best results. |
