​Whether it be strategic planning, product development or operational implementation, ConsulTide provides a vast array of consulting services to help you achieve your goals.
Our expertise and deep understanding of the peptide industry provide you with efficient, effective and creative solutions.
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​Najib Maslouh, Ph.D.,
Founder
About ConsulTide
Consulting with Purpose
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Over 30 years of CMC professional expertise covering peptide therapeutics from development through registration and commercialization.
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Exceptional records of accomplishment in the pharmaceutical and biotech industry.
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Recognized for value creation, building new capabilities, developing, optimizing and scaling up state-of-the-art manufacturing processes.
Services
Your Strategic Partner
STRATEGIC PLANNING
The Path to Success
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From Ideation to market approval.
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End-to-end Chemistry, Manufacturing and Controls (CMC).
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Identification of Contract Service Providers (CSP), technical support, request for proposal and tech transfer.
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Review and negotiations of Quality Agreement, Master and Commercial Supply Agreements.
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CSP network design.
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Regulatory, technical, and supply chain risk mitigation.
IMPLEMENTATION
A Cohesive and Comprehensive Approach
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​​API and DP stability, impurities identification and characterization.
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Process design, process development and characterization.
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Process performance qualification and analytical methods validation.
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Auditing, reviewing and editing cGMP written records, CMC regulatory and quality documents.
OPTIMIZATION
Expert Guidance
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Quality by Design, FMEA for optimizing and controlling the quality of API and DP.
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Manufacturing process optimization and elimination of bottle neck unit operations.
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Manufacturing process scale-up and efficiency gain to realize economies of scale and ensure cost effective operations.
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Manufacturing automation implementation to streamline workflows by removing human process errors and delays to keep operations lean, efficient and productive.
ConsulTide Reviews
At ConsulTide, we do everything we can to make sure our customers are satisfied with our work. Since 2017, we have provided tailored consulting services to clients from all over. We have guided them through the most crucial decisions and supported them throughout the entire drug development process.
I would like to thank ConsulTide for their outstanding contributions to the peptide CMC project.
Their comprehensive understanding of every aspect of peptide chemistry, manufacturing, and control is impressive and professional. ConsulTide made a valuable contribution. ​
We appreciate ConsulTide's effort and contributions and look forward to continuing our cooperation in the future.
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Ehab Alshamleh, Senior Director, DS & DP Development & Manufacturing, IMV
![SmartHeadShot[6].jpg](https://static.wixstatic.com/media/42d96e_c1b5c988f2864575ac4802574250ceb7~mv2.jpg/v1/fill/w_75,h_113,al_c,q_80,usm_0.66_1.00_0.01,blur_2,enc_auto/SmartHeadShot%5B6%5D.jpg)
ConsulTide’s extensive expertise covering peptide therapeutics from development through registration and commercialization is readily apparent, and the reason we engaged ConsulTide to provide hands-on leadership for our clinical-stage cyclic hexapeptide therapeutic program. Through ConsulTide’s industry network, we promptly selected a top-tier CDMO to address our immediate peptide synthesis needs. ConsulTide defined our project’s requirements in collaboration with the CDMO and managed the project to ensure the timely achievement of our goals. Under ConsulTide's continuing leadership, we are now progressing on to developing, optimizing, and scaling up state-of-the-art manufacturing processes for this program.
I recommend ConsulTide highly, and without reservation as an exemplary CMC professional team.
Tom Smart, CEO, Gravitas Therapeutics.
Over the last 5 years, ConsulTide was a key contributor for trouble shooting, process optimization, site selection, technical transfer, manufacturing strategy, and process development for a second generation process. It has been a pleasure working with ConsulTide. Their calm demeanor, collaborative disposition, and passion for delivering results makes ConsulTide an outstanding team during challenging times.
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Ahmad Sadr, Senior Vice President, Technical Operations, Apellis Pharmaceuticals
ConsulTide brought in-depth knowledge and extensive experience in peptide synthesis from development through registration and commercialization. We have engaged ConsulTide to provide leadership for our two clinical-stage peptides. Through ConsulTide’s industry network, we promptly selected two CDMOs to address our immediate peptide synthesis needs. ConsulTide defined our project’s requirements in collaboration with the CDMO and managed the project to ensure the timely achievement of our goals. ConsulTide was instrumental during the EOP2 meeting with the FDA. ConsulTide's strategy in terms of impurities characterization, development of UHPLC analytical methods and scale up were well received and accepted for the Phase 3 development by the FDA. Under ConsulTide's continuing leadership, we are now progressing on to developing, optimizing, and scaling up manufacturing processes for both peptide programs. I highly recommend ConsulTide as an exemplary CMC professional team.
Sunil Shah, Senior Vice President CMC Development, Equillium Bio
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