Regulatory Framework: Understanding and adhering to regulatory requirements set by national regulatory agencies (e.g., FDA in the US, EMA in Europe, PMDA in Japan) and international standards (e.g., ICH guidelines) applicable to pharmaceutical development, manufacturing, and distribution. Quality Management Systems (QMS): Implementing and maintaining a robust QMS that defines policies, procedures, and responsibilities for quality assurance, quality control, and quality improvement activities. This includes documentation control, change management, and deviation management processes. Audits and Inspections: Conducting internal audits to assess compliance with QMS and regulatory requirements. External regulatory inspections by authorities evaluate compliance with GMP, GLP, GCP, and other regulations. Preparation for and management of inspections are critical aspects of compliance. Documentation and Recordkeeping: Maintaining comprehensive and accurate documentation of all activities related to pharmaceutical development, manufacturing, and distribution. This includes batch records, validation documents, stability data, analytical records, and regulatory submissions. Quality Risk Management: Implementing a systematic approach to identify, assess, control, and mitigate risks to product quality, patient safety, and regulatory compliance throughout the product lifecycle. This involves risk assessments, risk control measures, and periodic review of risks. Supplier and Vendor Management: Ensuring that suppliers and contract manufacturers comply with GMP and other regulatory requirements through supplier audits, qualification processes, and ongoing monitoring of performance and compliance. This is crucial to maintaining the quality and consistency of raw materials and finished products. Training and Competency: Providing training programs to ensure that personnel involved in regulatory affairs and quality assurance are trained and competent in GxP principles, SOPs, regulatory requirements, and specific job responsibilities. Training helps maintain a knowledgeable workforce capable of ensuring compliance. Compliance Monitoring and Reporting: Monitoring compliance with regulatory requirements and QMS through metrics, KPIs, and regular reporting. Tracking deviations, CAPAs, and other quality metrics helps identify trends and areas for improvement to enhance compliance and product quality. Continuous Improvement: Implementing a culture of continuous improvement to enhance QMS, processes, and procedures based on audit findings, inspection observations, and feedback. This includes implementing corrective actions to address deficiencies and prevent recurrence, as well as proactive identification of opportunities for process optimization. Global Regulatory Alignment: Keeping informed about global regulatory trends and requirements to ensure alignment with international standards and regulations. This is particularly important for companies operating in multiple regions or exporting products internationally.

COMPLIANCE AND AUDIT - PharmReg Neoteric

To ensure optimal patient safety throughout the whole drug development process—from research to post-marketing operations—regulatory measures are strict. Ensuring patient safety necessitates maintaining regulatory compliance. Pharmaceutical items must therefore adhere to all laws, policies, and guidelines established by relevant authorities as they move through their life cycle. The implementation of quality systems and pharmacovigilance services also need to be regularly audited in order to be regularly reviewed and validated.

All pharmacovigilance systems, including their setup and functioning, are examined by our audit staff. Our group is dedicated to making sure that all pharmacovigilance procedures comply with legal standards, including FDA, E2E, GVP modules, E2B(R3), E2C(R2), and ICH guidelines. To make sure that the personnel of the company is aware of the need to maintain compliance with such regulatory services requirements, PharmReg Neoteric also offers training in PV Audit.

Services Include

Regulatory Framework: Understanding and adhering to regulatory requirements set by national regulatory agencies (e.g., FDA in the US, EMA in Europe, PMDA in Japan) and international standards (e.g., ICH guidelines) applicable to pharmaceutical development, manufacturing, and distribution.
Quality Management Systems (QMS): Implementing and maintaining a robust QMS that defines policies, procedures, and responsibilities for quality assurance, quality control, and quality improvement activities. This includes documentation control, change management, and deviation management processes.
Audits and Inspections: Conducting internal audits to assess compliance with QMS and regulatory requirements. External regulatory inspections by authorities evaluate compliance with GMP, GLP, GCP, and other regulations. Preparation for and management of inspections are critical aspects of compliance.
Documentation and Recordkeeping: Maintaining comprehensive and accurate documentation of all activities related to pharmaceutical development, manufacturing, and distribution. This includes batch records, validation documents, stability data, analytical records, and regulatory submissions.
Quality Risk Management: Implementing a systematic approach to identify, assess, control, and mitigate risks to product quality, patient safety, and regulatory compliance throughout the product lifecycle. This involves risk assessments, risk control measures, and periodic review of risks.
Supplier and Vendor Management: Ensuring that suppliers and contract manufacturers comply with GMP and other regulatory requirements through supplier audits, qualification processes, and ongoing monitoring of performance and compliance. This is crucial to maintaining the quality and consistency of raw materials and finished products.
Training and Competency: Providing training programs to ensure that personnel involved in regulatory affairs and quality assurance are trained and competent in GxP principles, SOPs, regulatory requirements, and specific job responsibilities. Training helps maintain a knowledgeable workforce capable of ensuring compliance.
Compliance Monitoring and Reporting: Monitoring compliance with regulatory requirements and QMS through metrics, KPIs, and regular reporting. Tracking deviations, CAPAs, and other quality metrics helps identify trends and areas for improvement to enhance compliance and product quality.
Continuous Improvement: Implementing a culture of continuous improvement to enhance QMS, processes, and procedures based on audit findings, inspection observations, and feedback. This includes implementing corrective actions to address deficiencies and prevent recurrence, as well as proactive identification of opportunities for process optimization.
Global Regulatory Alignment: Keeping informed about global regulatory trends and requirements to ensure alignment with international standards and regulations. This is particularly important for companies operating in multiple regions or exporting products internationally.