Efficient, High Quality Production
Implement a Sustainable Quality Culture
We help regulated manufacturing customers create sustainable, high performance, reliable operations. We understand how to implement a reproducible, cost-effective, and compliant process resulting in safe, effective, available products. By focusing on product and process understanding, we achieve high quality, lower cost manufacturing; we strip away the “compliance for compliance sake” approach, and reduce the cost of quality/compliance.
Beginning with initial concept development and refinement, our consultants can help you plan a product development strategy that will ensure you meet your customers’ needs throughout the lifetime of your regulated product. We understand as a product matures, your needs often change including the need to move manufacturing operations amongst your own manufacturing locations or to new locations around the world.
Build a Robust Supply Chain
We also understand that in today’s global business environment, access to current information from across your supply chain is critical. Supply chain risk management and operational success requires the right mix of technology, lean business systems and critical analysis. Our supply chain experts help you analyze your processes and suppliers to preserve the quality of your product and achieve industry-leading supply chain performance, regardless of the scale of your operations.
Our consultants proactively help you upgrade business processes, improve training, execute operations that are compliant with current international Good Manufacturing and Distribution Practices, achieve regulatory compliance, and build quality into the site culture. The result is a high-performance operation based on product and process understanding, and focused on delivering quality products efficiently and reliably.
Our consultants are knowledgeable in a variety of regulated industries around the world including:
- Branded and generic (including OTC) and pharmaceuticals and biologics
- Medical device manufacturing
- Blood products
- Tissue and cellular therapies
- Food and dietary supplements
- Cosmetics and personal care products
Our portfolio of projects includes:
- Bringing novel regulated products and technologies to the market
- Preparing processes, systems and personnel for inspections and certifications
- Building robust supplier management programs
- Transferring products from one manufacturing facility to another
- Implementing science and engineering based risk management programs
- Developing robust international regulatory strategies
- Preparing and submitting product and facility registrations
- Determining sources of and implementing controls to reduce process variation
We have provided these services around the globe, and we can deliver for you: as a focused team performing an objectives-based project, or via one or more key individuals to work as part of your internal team. Contact us at firstname.lastname@example.org for your customized solution or visit our library for whitepapers and case studies showing our depth of experience and the value we deliver.