BIOTECHNOLOGY & PHARMACEUTICAL QUALITY ASSURANCE CONSULTING
Experienced Biotech & pharmaceutical quality assurance consultants improve quality and exceed the highest industry standards.
Quality Assurance Consultants assess a company’s processes, procedures, and products to ensure compliance with the latest industry standards and regulatory requirements. We also work with our clients to prepare for regulatory audits, and identify potential areas of improvement and any potential risks.
Quality assurance is an essential part of any successful biotech or pharmaceutical business. Our experienced Quality Assurance Consultants provide life science companies and their employees with valuable insight into their processes, procedures, and products to ensure they are consistently exceeding the highest standards and improving quality required by the industry. VRT will also provide training to ensure all regulatory guidelines are met by the organization.
Perform the Quality system audits as per client`s requirement in accordance US CFR part 210 and 211, ICH and EU GMP for pharmaceutical and Biological companies Computer System Validation (CSV) and electronic documentation software modules and audit trails, Auditing and qualification of vendors and quality oversight of Vendors/ suppliers, CMOs/CROs and quality agreements. Prepare, review of Client`s dossiers -IND/ANDA/DMF to US Regulatory Agencies. Conduct audits on various software applications like Computer System Validation (CSV), Laboratory Management System (LIMS), SAP, eQMS, LMS, data analytics
Quality Assurance Consulting Services Include:
Data Integrity & Compliance
Providing platforms and well-defined processes for improving the accuracy, completeness, consistency and security of data.
Quality Systems and Records
VRT will design, implement and maintain quality management systems with different modules for initiating records such as deviations, investigations, change controls and CAPA’s.
Audit Preperation
Our consultants offer services for regulatory, internal and external data integrity audits in regard to readiness, engagement, interaction, pre-approval inspections (PAI), data audits and gap assessments.
What Does Quality Assurance Consulting Involve?
Quality Assurance Consultants work closely with clients to develop strategies for improving quality control measures, ensuring compliance, and mitigating risks wherever possible. All relevant regulatory requirements are considered during the assessment process to ensure that all applicable regulations are being met.
After conducting an assessment, the quality assurance consultant provides a detailed report outlining any deficiencies in quality control systems as well as recommendations for improvement. These recommendations include changes to existing processes or policies, new procedures or guidelines, or additional training for employees on quality control measures.
Leveraging a consultant’s knowledge of quality control systems can help your business to reduce costs while increasing efficacy, operational efficiency, compliance, and customer satisfaction.
Knowing that you have taken proactive steps toward mitigating risk while staying ahead of industry standards is an assurance of operational quality. Whether you’re looking for one-time consultation services or long-term support solutions, working with a qualified Quality Assurance Consultant from BioPharma Consulting Group is an excellent way to invest in the long-term success of your business.