We specialize in collaborating closely with pharmaceutical companies to craft robust Chemistry, Manufacturing, and Controls (CMC) strategies that guarantee the quality, safety, and efficacy of your drug products. Our seasoned team provides expert guidance on formulation development, process optimization, analytical method development, and stability studies, ensuring compliance with regulatory standards.

Our seasoned consultants are dedicated to helping companies establish and maintain robust Quality Management Systems (QMS) that uphold pharmaceutical products to the highest regulatory standards and quality benchmarks. From conducting meticulous audits to implementing effective quality risk management practices, our tailored approach ensures consistency and compliance throughout your operations. We provide invaluable training on Good Manufacturing Practices (GMP) and other pertinent quality guidelines, empowering your team to navigate complex regulatory landscapes with confidence.

Our tailored programs provide the tools and techniques to identify and reduce defects, minimize variation, and elevate process performance. With training programs available at various levels – from Yellow Belt to Master Black Belt – our expert consultants empower your employees to effectively lead and participate in Lean Six Sigma projects. Our comprehensive approach gives your team the skills and knowledge needed to drive continuous improvement and achieve measurable results.

We specialize in Gap Analysis and Remediation services designed to fortify your organization's compliance and risk management efforts. Our seasoned consultants meticulously assess your processes, systems, and documentation to pinpoint areas of non-compliance and potential risks. With thorough analysis, we craft comprehensive remediation plans tailored to your specific needs, ensuring alignment with regulatory standards and best practices. Our goal is to equip your organization with the tools and strategies needed to mitigate risks effectively and achieve sustainable compliance.

Our expert consultants offer tailored training programs, exam preparation courses, and practice materials designed to ensure success. With our proven methodologies and personalized approach, we empower candidates to confidently navigate certification exams and excel in their respective fields. Whether you're pursuing Lean, Six Sigma, or other relevant certifications, our team is dedicated to providing the guidance and support needed to achieve your professional goals.

The internet, software, and technology are so pervasive that we can’t remember having ever lived without them. They make our lives simpler, but behind the curtain are fluctuating challenges in protection and monetization; challenges that our firm stays two steps ahead of. We’ve helped engineers, inventors, gaming startups, and entrepreneurs develop, license, sell, and maintain ownership over their creations. We’ve also negotiated purchasing and partnership agreements for larger investment companies looking for their unicorn.