Good Manufacturing Practices (GMP) Services
The Weinberg Group is the Industry Leader in Regulatory & cGMP Services
The Weinberg Group (TWG) provides comprehensive, hands-on GMP Quality Compliance services to the pharmaceutical, medical device, and biotechnology industries. We have been providing GMP consulting services to clients worldwide for the past 35 years.
Our GMP consulting services are characterized by:
- Knowledge: We know what is important to FDA.
- Experience: Seasoned GMP consultants, each with at least ten years in GMP.
- Holistic Approach: In addition to process and procedures, we review the organization, employee engagement, systems, training, etc.
- Root Cause Analysis: We focus our resources on determining and rectifying the root cause.
- Strong Project Management: Regardless of project size, each engagement is assigned a project manager with responsibility for project success, acting as a single point of contact for you and your team.
- Value: Our consultants are competent and efficient, producing results as quickly as possible. We do not believe, as some of our competitors do, that the best results are obtained by engaging legions of consultants to rewrite SOPs.
- Speed: Time is critical when manufacturing issues arise. We mobilize quickly to assist our GMP clients worldwide.
Benefits of Having a GMP Consultant
GMP Consultants can bring expertise and experience that your business does not have. They can help manage and complete a compliance project that requires specialized skills or help get work done efficiently.
The Weinberg Group: GMP Compliance Experts
As our client, you can expect a partner that will not only be hands-on, but will also work alongside you to provide quality compliance services as well as the strategy and training to help you improve your quality systems, thus mitigating future risk.
We will work with you to identify the appropriate GMP Consultant based on your organizational requirements and needs. We will then work with you to define, draft, and execute a plan to optimize your GMP quality and compliance programs.
As a Global leader in regulatory and compliance services for over 35 years, The Weinberg Group has provided biotech, medical device, and pharmaceutical consulting services to companies worldwide. We have consulted with companies of every size on every continent supplying them with viable and efficient GMP Compliance solutions. The Weinberg Group takes a proven, active approach to listening and addressing our clients’ specific needs to ensure their quality and regulatory operations are in compliance with current industry standards, as well as FDA and international regulations. The Weinberg Group is the GMP Services company of choice for the pharmaceutical, medical device, and biotechnology industries.
GMP Service Offerings
By utilizing our consulting services, you can address the following:
Design of Quality Systems for:
- Facilities and Equipment
- Laboratory controls
Within the Quality System, we can provide the following services:
- Policies, Standards, SOP Preparation, and/or Optimization
- Batch Record Review
- Remediation Project Management
- Quality Systems Development, Assessment, Remediation
- Root Cause Investigations and Corrective Action/Preventive Action (CAPA) Remediation
- Third-party GMP and GLP Compliance Auditing
- Mock FDA/International Regulatory Agency Inspections & PAI Readiness
- Due Diligence Compliance Inspections, Audits and Assistance
- FDA Actions (483 Observations, Warning Letters, Consent Decrees) Remediation
- Data Integrity Compliance
- Mergers & Acquisitions (M&A) regulatory integration