HALLMARK

& T E A M P E R FO R M A N C E

Dr. Eugene Livshits

Dr. Eugene Livshits is an innovative, results-driven leader and scientist with over 25
years of experience spanning global regulatory practices, analytical chemistry,
quality assurance, and manufacturing for solid dosages, liquid products,
injectables, biologics, medical devices, and combination products.

REGULATORY PRACTICE
QUALITY ASSURANCE
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ANALYTICAL CHEMSITRY

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Client Solutions

1 6
Ensuring Compliance Across Complex Regulatory Landscapes: Enhancing Quality Assurance Protocols:
Helps organizations navigate stringent regulatory environments Partners with leadership teams to builds robust quality assurance
globally, ensuring compliance with CGMP, CGLP, CGCP, ISO 9000, frameworks that reduce errors, improve product consistency, and
ISO 17025 and other critical standards to avoid costly penalties elevate overall quality standards, safeguarding the brand and
and maintain operational integrity. building customer trust.

2 7
Streamlining Product Development Pipelines: Facilitating Rapid Adaptation to Regulatory Changes:
with leadership to enhance product development efficiency, Ensures organizations stay agile and compliant amidst evolving
accelerating time-to-market through best practices in R&D and global regulations, reducing risks of non- compliance and
regulatory alignment for solid, liquid, injectable, combination and ensuring continuous operational excellence.
biologic products.

3 8
Optimizing Leadership in Manufacturing Operations: Improving Cross-Functional Regulatory Communication:
Enhances leadership competencies in manufacturing processes Bridges communication gaps between regulatory, technical, and
across all phases, identifying bottlenecks and implementing business teams, ensuring seamless collaboration on critical
solutions for solid and liquid dosage forms, injectables, submissions (e.g., ANDA, NDA, 505(b)2, IND, BLA, IMPD, CTA, PMA,
combination and biologic products, which increases output and OPDP) and enhancing organizational alignment with compliance
reduces costs. goals.

4 9
Implementing Advanced Analytical Techniques for Product Building High-Performing, Compliance-Focused Teams:
Testing: Provides mentorship and training to build compliance-focused,
Establishes and manages advanced analytical testing protocols, quality-driven teams, empowering leaders and managers with
increasing precision in product evaluation and reducing the risk tools to maintain high standards and improve organizational
of market recall or regulatory scrutiny. resilience.

5 10
Cultivating a Quality-First Culture: Supporting Effective Crisis Management, Product Recalls and
Fosters a culture of quality and compliance across all levels of Product Seizure:
the organization, ensuring all teams understand the importance Develops contingency plans and crisis management strategies to
of rigorous standards and are aligned with the organization's swiftly address and resolve issues related to product recalls,
mission of excellence. quality lapses, or compliance violations, mitigating risks and
protecting brand reputation.

S p e c i l i z at i o n &
Expertise
Known for his expert problem-solving and strategic business insight, Eugene excels at
bridging technical and business perspectives, fostering productive communication
across diverse teams. A natural mentor and accomplished manager, he develops and
leads teams technical operations for pharmaceutical companies consistently
delivering impactful solutions and driving operational success.

AREAS OF EXPERTISE INCLUDE: Dr Livshits has built multiple pharmaceutical

and nutraceutical companies from the
I am always REGULATORY PRACTICE INCLUDING ANDA, NDA, 505(B)2, IND,
BLA, IMPD, CTA, PMA, OPDP AND CHEMISTRY,
ground up to successful operations. Led
several pharmaceutical companies from
here when you MANUFACTURING, AND CONTROLS (CMC), ALSO INCLUDING
GLOBAL REGULATORY
critical situations, including warning letters,
product seizures, and recalls, to fully
need me for QUALITY ASSURANCE compliant and thriving operations. He
Increased market share for pharmaceutical
big problems
CGMP, CGLP, CGCP ISO 9000 AND ISO 17025
ANALYTICAL METHODS AND INSTRUMENTATION companies from $0.65 to $23 by optimizing
operations, expanding product lines, and
or quick
PRODUCT DEVELOPMENT
COMPLIANCE establishing robust Good Manufacturing
Practices (GMP). Over the years, conducted
answers ALL PHASES OF MANUFACTURING OF SOLID AND LIQUID DOSAGE comprehensive cGMP training for numerous
pharmaceutical and nutraceutical companies,
and solutions
PRODUCTS, INJECTABLE (INCLUDING AUTO INJECTION),
BIOLOGICS AND MEDICAL DEVICES driving consistent adherence to industry
NUTRACEUTICALS standards.
COSMETICS.

DR. LIVSHITS
HIGHLIGHTS
YEARS OF EXPERIENCE IMPACT
PhD in Chemistry with over 25 years of industrial experience. Provide consultancy services to develop and transform regulatory
policies and processes related to chemistry, manufacturing, and
Vice President and Chief Technical Affairs Officer in multiple controls (CMC) to enable sustainable compliance station.
companies.
Help multiple companies to overcome Product Development and
Provide mentoring, consulting and coaching services to the Manufacturing challenges in order to supply customers with
different level of Industry leaders. excellent quality products.
Through the years helping large number of the companies to
achieve their goals in gross, quality and acceleration Provide expertise and consulting capabilities from early stage to
medicines to market. commercialization for multiple products.

DR. LIVSHITS
S I G N AT U R E A P P ROAC H
We’re here to support all our clients, new and longstanding, whether it’s a bit of extra advice or a detailed
consultation. With Eugene’s strategic foresight and contingency plans always in place, we’re ready to assist
with quick responses and expert suggestions for questions from various regulatory authorities. Following
through on commitments is fundamental to building trust and respect in our support.

SUSTAINABLE FUTURE DESIGN ASSURANCE

Intelligent and scientific approach to Finding the solution for Help to make company
resolve the Industry difficulties and every stage of the Industry operation compatible and
achieve sustainable growth. journey. future-proof.