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Enterprise Business Solutions, Inc., Columbus, Ohio, 43220 (Established 2013) & Naperville, IL
Enterprise Business Solutions, Inc., Columbus, Ohio, 43220 (Established 2013) & Naperville, IL
Board-Level Strategy Advisor | Managing Director, Enterprise Bx (Pharma/BioTech Consultancy) Columbus, OH & Naperville, IL | Ex-Founder & VP, (TQ Pharma (NOW MENA Leader))
Board-Level Strategy Advisor | Managing Director, Enterprise Bx (Pharma/BioTech Consultancy) Columbus, OH & Naperville, IL | Ex-Founder & VP, (TQ Pharma (NOW MENA Leader))
(Executive & Consultant | Product Development & Manufacturing | Startup & Growth Leader)
(Executive & Consultant | Product Development & Manufacturing | Startup & Growth Leader)
Driving Pharmaceutical Development: Visionary Leader with Expertise in Small & Large Molecules (incl. Oligonucleotides): Navigate Drug Development with Confidence. Dr. El-Khateeb brings over 20 years of experience in drug development Life-Cycle. He has a proven track record of solving complex problems, like revolutionizing topical generic development and navigating large-scale clinical trials combined with his strategic expertise honed through board of directors roles, positions him to guide clients seamlessly through the entire product lifecycle. His expertise in CMC, project management, and team building positions him to guide clients through the entire product development lifecycle.
Driving Pharmaceutical Development: Visionary Leader with Expertise in Small & Large Molecules (incl. Oligonucleotides): Navigate Drug Development with Confidence. Dr. El-Khateeb brings over 20 years of experience in drug development Life-Cycle. He has a proven track record of solving complex problems, like revolutionizing topical generic development and navigating large-scale clinical trials combined with his strategic expertise honed through board of directors roles, positions him to guide clients seamlessly through the entire product lifecycle. His expertise in CMC, project management, and team building positions him to guide clients through the entire product development lifecycle.
Education: Dr. El-Khateeb boasts an impressive educational background, holding a Ph.D. in anti-cacer drugs metabolism from the prestigious University of Queensland and a postgraduate degree in Pharmacological Sciences from the State University of New York at Stony Brook. This foundation equipped him with a deep understanding of drug development processes and the scientific underpinnings of pharmaceutical products.For more information click here
Check our Current Partners, Collaborators, and Clients:
Check our Current Partners, Collaborators, and Clients:
2- Sana Pharma Industries - A state of art GMP manufacturing site for medicinal products, medical devices, herbal products and solid cosmetics. The company has an active pipeline of niche pharmaceutical products marketed in the MENA region, Europe, and soon in USA under Sana Pharmaceutical branding. https://www.sana-pharma.com/
2- Sana Pharma Industries - A state of art GMP manufacturing site for medicinal products, medical devices, herbal products and solid cosmetics. The company has an active pipeline of niche pharmaceutical products marketed in the MENA region, Europe, and soon in USA under Sana Pharmaceutical branding. https://www.sana-pharma.com/
3- Maya Cosmetics Inc - It is America's leading Halal Nails & Cosmetics brand focusing on the halal, kosher and vegan marke (https://www.maya-cosmetics.com)
3- Maya Cosmetics Inc - It is America's leading Halal Nails & Cosmetics brand focusing on the halal, kosher and vegan marke (https://www.maya-cosmetics.com)
4- Tamsco Inc - Global Leader in Medical Equipment Manufacturing - Tamsco is a mid-sized instrument manufacturer’s sales & marketing arm, based in Chicago. Our family-owned factories have been producing high-quality stainless steel instruments and tools for 60 years. We currently export to about 40 countries. https://tamsco.biz/about-us/
4- Tamsco Inc - Global Leader in Medical Equipment Manufacturing - Tamsco is a mid-sized instrument manufacturer’s sales & marketing arm, based in Chicago. Our family-owned factories have been producing high-quality stainless steel instruments and tools for 60 years. We currently export to about 40 countries. https://tamsco.biz/about-us/
4- Sana Pharmaceutical Research - A fast growing independent research company focused on the development of pharmaceutical products with outstanding quality.
4- Sana Pharmaceutical Research - A fast growing independent research company focused on the development of pharmaceutical products with outstanding quality.
5- Glorious Skincare Chicago LLC- Glorious products bring together the finest materials and stunning design to create something very special. https://glorious-skincare.com/
5- Glorious Skincare Chicago LLC- Glorious products bring together the finest materials and stunning design to create something very special. https://glorious-skincare.com/
Yousffi, M. Ex-FDA Independent I QA I 18+ years I FDA Readiness & Audit I FDA Remediation
Quality, GxP (GMP, GCP, GVP, GLP, GDP and CSV) Auditing and Remediation.
Quality, GxP (GMP, GCP, GVP, GLP, GDP and CSV) Auditing and Remediation.
Quality Assurance Expert with Extensive GxP Experience (EX FDA). A recognized expert in Quality Assurance (QA) with extensive GxP experience (including time at the FDA), Mr. Yousffi tackles complex challenges and mitigates FDA citation risks. His 18+ years across GMP, GCP, and other GxP disciplines ensure clients navigate regulatory hurdles with confidence. Yousffi's expertise extends beyond auditing, encompassing QMS development, documentation management, and supplier oversight – all focused on achieving operational excellence in quality assurance.
Quality Assurance Expert with Extensive GxP Experience (EX FDA). A recognized expert in Quality Assurance (QA) with extensive GxP experience (including time at the FDA), Mr. Yousffi tackles complex challenges and mitigates FDA citation risks. His 18+ years across GMP, GCP, and other GxP disciplines ensure clients navigate regulatory hurdles with confidence. Yousffi's expertise extends beyond auditing, encompassing QMS development, documentation management, and supplier oversight – all focused on achieving operational excellence in quality assurance.
Education: Mr Yousffi holds a master degree from the University of Illinois Chicago. For more information click here.
Dr. George Sarkis - Biologics Leader
Research & Development | Cell & Gene Therapy | Novel High-Throughput robotics |Proteomics | Analytical Development (Ph.D.)
Biotech Development /Bioanalytical Consultants
Biotech Development /Bioanalytical Consultants
Biologics R&D Leader
Biologics R&D Leader
Dr. Sarkis is a highly accomplished scientist with over 18 years of experience in the pharmaceutical industry, specifically in biologics research and development. His expertise lies in analytical development methodologies, scientific team leadership, and innovative problem-solving.
Extensive Experience: Proven track record in biologics R&D, including cell and gene therapy platforms.
Analytical Expertise: Hands-on experience with advanced analytical techniques like mass spectrometry and chromatography for characterizing small and large molecules.
Innovative Problem-Solver: Pioneered high-throughput robotics to expedite drug development and enhance molecule characterization.
Strong Leadership: Established and led high-performing scientific teams, fostering collaboration and excellence.
Regulatory Compliance: Ensured adherence to best practices and regulatory requirements throughout the development process.
Education and experience: Dr. Sarkis holds a PhD from the University of Florida, FL
Massachusetts Institute of Technology (MIT) focused on proteomics and biomarker discovery. For more information click here
S.M & E. (M.Sc.)
Regulatory Affairs Experts CMC | FDA Regulation Advice | Manage FDA | Submission Strategy
Proven Track Record: Independent Regulatory Affairs Consultants (>40+ combined)
Proven Track Record: Independent Regulatory Affairs Consultants (>40+ combined)
(Our consultants work closely with clients while maintaining their privacy)
(Our consultants work closely with clients while maintaining their privacy)
Frustrated by complex FDA regulations? Our independent Regulatory Affairs Consultant cuts through the red tape.
CMC Documentation: Ensure compliant product documentation.
Clinical Study Design & Management: Design strong clinical trials.
FDA Regulations Navigation: Navigate complex FDA requirements with ease.
FDA Meetings (PreANDA, Post ANDA etc) and controlled correspondences
Utilizes eSubmissions for efficient and streamlined filings.
Develops strategic submission plans to maximize your first-time approval chances.
Focus on your core business while we handle the regulatory complexities. Contact us today for a smoother FDA journey!
Education: Regulatory Affairs Law and and high education degrees in biological sciences from US-based prestigious universities with all regulatory affairs licenses such as RAC-US.For more information click here
Dr. GA (M.D.) Clinical Management
Experienced Medical Doctor Clinical Management
Clinical Operations & Project Management Expert (20+)
Clinical Operations & Project Management Expert (20+)
(Our consultants work closely with clients while maintaining their privacy)
(Our consultants work closely with clients while maintaining their privacy)
A highly experienced professional with 20+ years in research excels at leading clinical trials. Their expertise, backed by a Doctorate in Medicine, PMP certification, and ACRP-CRA credential, delivers successful global studies for various clients. Proven skills encompass managing all aspects of clinical trials, from protocol development to data review and budget control. They excel at leading cross-functional teams, ensuring regulatory compliance and project timelines are met.
Our partner boasts a successful track record from education as physicians and managing clinical programs for major pharmaceutical companies such as AstraZeneca/MedImmune, Vergent Bioscience, Syneos Health, Daiichi Sankyo, Inc., Precision for Medicine, NJ. For more information click here
Dr. Shekhani, S.
Dr. Shekhani, S.
End-to-End Chemical Drug Substance Development & CMC Expert (Ph.D.)
End-to-End Chemical Drug Substance Development & CMC Expert (Ph.D.)
Development, Scaleup, and Manufacturing Chemical Drug Substances - Analytical Development and Validation
Development, Scaleup, and Manufacturing Chemical Drug Substances - Analytical Development and Validation
Pharmaceutical & Biotech Leader (25+)
Expertise: Quality (APIs/Drugs), Regulatory Affairs, GMP (US/EU), Project Management.
Science: Deep knowledge of Analytical & Organic Chemistry (Biologics & Small Molecules).
Process Optimization: Develops multi-step pathways, improves processes, troubleshoots discovery challenges.
Team Leader & Mentor: Builds strong teams, fosters development.
Documented Success: Backed by patents, publications, awards.
cGMP Champion: Ensures compliance through audits, assessments, outsourcing expertise.
Education: Ph.D in the field of chemistry, the State Univeristy of New York.For more information click here
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