BIOTECHNOLOGY & PHARMACEUTICAL PROJECT MANAGEMENT CONSULTING
Our project management consultants implement proven solutions for Life Science companies.
At VRT Pharma Consulting Group, our biotechnology and pharmaceutical project management (PM) consultants specialize in quality control and quality assurance management to set the most efficient company goals and implement customized strategies for successful achievement of every objective to ensure quality throughout all phases of drug product discovery to commercialization.
Our consultants are experienced in providing tailored solutions to fit the needs of growing businesses. VRT project management services include oversight of internal and external projects related to Quality Control, Quality Assurance and Contract Organization (CxO) management for tasks such as external method validations, method transfers, risk management, process optimization, business intelligence and regulatory compliance to ensure projects are completed to implement necessary strategies and meet timelines.
Project management solutions include:
External Contract Organization (CxO) Management
For companies relying on external testing and/or manufacturing data handling, communication must be of the highest quality. VRT offers PM consultants to provide paramount infrastructure and business relationships to excel in external method validations, method transfers, risk management, process optimization, business intelligence, and regulatory compliance.
Regulatory Compliance
VRT consultants are industry experts knowledgeable in global biotechnology and pharmaceutical regulations in guiding and preparedness for United States (FDA),Quality Oversight for CRO and CMO, Regulatory Filing, European (EMA), Singapore (HSA), Japan, Brazil, Turkey, including International Council of Harmonisation (ICH) guidelines. We ensure companies meet all regulatory standards for quality control and quality assurance processes.
Process Optimization
Our initiatives focus on optimization opportunities to ensure businesses apply the best industry practices. We leverage from regulatory standards, guidelines and experience to streamline all operations, minimizing cost and maximizing efficiency with no impact to quality, integrity and compliance.
Business Intelligence
With leading industry experience, our consultants have diverse knowledge and understanding of the latest technologies in a variety of data management systems, equipment and software. We can provide expert advice for advanced business tool options which are fully compliant and suitable to meet client needs for data control and to protect data integrity.
Quality Risk Management
Our experts will assist in identifying risks, assign risk mitigation plans and implement administrative and process controls to minimize and eliminate impact.