Compliance aligned with rapid execution
With a diverse team of experts and a deep understanding of life-science market, we empower businesses to navigate complexities and seize opportunities at every stage of their journey. Our strategic insights and innovative approach ensure sustainable growth and success in an interconnected global economy.
We work with your engineering team to review designs and verify alignment as part of the commissioning, qualification, and validation (CQV) process, increasing efficiencies, reducing cost, and ensuring GxP compliance.
We follows the latest best practices outlined by the FDA, EMA, ICH, WHO, ISPE, PDA, ISO, and other global regulatory agencies to ensure your project meets all regulatory requirements while adhering to your company’s site-specific procedures.
We offer Process Engineering services that focus on designing, optimizing, and managing within compliance all manufacturing operations. Our goal is to provide customized design, which is efficient, reliable, and cost-effective.
Capitalize on our extensive experience in pharmaceuticals, biotechnology, and medical device industries for comprehensive validation solutions.
We provide project control services through all phases of greenfield and brownfield capital projects, including conceptual design, basis of design, detailed design, procurement, construction, mechanical and substantial completion, as well as CQV and other project deliverables.
We provide the process of transferring knowledge, technology, and intellectual property from one organization or entity to another. This could involve transferring information about a product, process, or technology from research and development to manufacturing, or from one manufacturing site to another.
Specializing in deviation/investigation, CAPA and Change Controls, we develop solutions that address your quality and regulatory compliance processes. Protect your business and increase your efficiency by leveraging our strategy to manage systems implementations, process improvement, audits, and remediation of problems.
Ranging from pre-approval to post-approval, and from intellectual property to FDA approval, we strategized cost-effective, high-quality regulatory affairs solutions for lifecycle maintenance of your pharmaceutical products.
We have the resources you need to design a clinical program that can increase efficiencies across the board. Whether you’re a small biotech start-up looking to stretch your cash and design the ideal clinical trial or a large, multi-national pharmaceutical company looking for a second opinion, we have the expert clinical data managers to offer solutions at every stage of the clinical drug development process.
We provide consultation that streamlines your end-to-end drug safety surveillance activities for investigational and post-market products. Our drug safety and risk management solutions allow you to focus on managing your core business, while we create a strategy that supports patient safety and protects your company.
Our lean organizational structure enables us to deliver premium services at a fraction of the cost charged by larger consulting firms. As a result, you can now access high-quality support without exceeding your budget.
We believe in building long-term relationships based on trust and mutual success. We are committed to understanding your unique needs and goals delivering tailored solutions that exceed your expectations.
WHO WE ARE
From our inception, we’ve maintained a singular focus on working with Life Science companies and the industry’s leading candidates. We leverage our experienced, customer-facing team, vast network of Life Sciences professionals, to become your trusted advisor and empower you to achieve your goals. We work closely with you to listen to your needs, consult you on the most strategic solution, and partner with you to deliver the solution. We are dedicated to solving global industry challenges through innovative solutions. With a proactive attitude and a focus on creating synergies, we strive to foster sustainable growth across the life science sector.