The good thing about having Elexes at your side while developing biologics or drugs is that we have the expertise at all stages of drug development. Whether you are at the initial development stage or post-approval stage, we can offer you the best support in building and executing a CMC strategy customized to your drug’s unique composition, use, and formulation process.
CMC Consulting
Having robust Chemistry and Manufacturing Controls (CMC) is one of the essential things not just on the regulatory compliance front, but also for the safety of patients. At Elexes, we understand this and have experts who will assist you in understanding all the CMC requirements and help you design and implement risk-based, phase-appropriate CMC solutions for your Biologics or Drug.
We have a dedicated team of experts who have years of experience in CMC consulting.
With us, you can get support for
- IND, NDA, BLA, ANDA Strategic Guidance
- Regulatory Dossier Writing
- Quality Agreement and SOP Set Up
- Quality System Establishment
- GMP Pre-approval Inspections
- US CDMO Search for Manufacturing
- Process Validation Protocol Review
- FDA Inspection 483 Remedy
- DMF Writing
- Coordination with Clinical Development Timelines
- IND Maintenance
- Post-approval Lifecycle Management
Wish to know more?
Remediation strategic consulting
If you are among those biologics or drug companies who wish to get best compliance assurance program, all you have to do is contact us and we will assist you through the entire regulatory clearance & approval journey.
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Client Testimonials
What Our Clients Say About Us?
Tom Birney
CEO Masterlink, Arizona
“Great work! Elexes team gave our organization immense support. Apart from being knowledgeable, and thorough; they were very responsive. All these are excellent virtues that I would look for when choosing a consulting firm.
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing. “
Linda Pan
Sr. Exe Treedental, Hong Kong
“I’m a fan! We worked with Elexes on import-export regulations, and couldn't have asked for a better expert. Elexes' team was very patient in answering all our questions and guided us on every step. Will definitely work with them again!
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They are very responsive and have done a great job with our regulatory projects and document control set-up. They were easy to contact and were quite quick at understanding the nuances of our product. “
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They’re always helpful and proactive. They are thorough and have provided invaluable support to us on import, labels, and registrations. “
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
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Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Created regulatory-compliant supplement fact sheets for multiple products. Their work helped us to sell within domestic & international markets without any problems. They were accurate and the turnaround time was amazing. “
Kurt Sysock
CEO Radformation, New York
“ Elexes promised and delivered a go-to organization for FDA regulatory and quality systems work. They have outperformed every expectation we had. “