CMC aligned with clinical studies
ACI has hand-selected a team of subject matter experts to provide CMC Solutions in the U.S. and beyond. Given the interconnectivity between CMC, and activities to demonstrate safety and efficacy, ACI is able to streamline the development process by integrating all factions of product development onto one team.
Our CMC team has a track record that demonstrates its expertise in successfully developing veterinary products with worldwide regulatory approvals. All areas of CMC solutions are offered by the team: from project and C(D)MO management, API process chemistry, formulation and manufacturing process development, analytical methods development and validation, Quality Assurance, Quality Control, and regulatory guidance.
Our CMC expertise
A highly experienced team will guide you from concept to treatment.
- 150 years of experience across our team
- Experience in more than 50 countries
- Risk managers who know exactly what to do and what not to do
- Expertise in all CMC areas
- Former CMC experts from global pharmaceutical companies
Niki Waldron
Formulation Development / Project Management
Niki brings over 35 years of experience in animal health formulation development, covering pre-formulation, formulation, manufacturing, scale-up and validation across various dosage forms. She has also managed CMC regulatory submissions and has eight years of project management experience overseeing CDMOs.
Mark Steele
Regulatory Affairs, Formulation, and Manufacturing
Mark has 28 years in regulatory affairs, including new product submissions, post-approval maintenance, and global registration support. His work spans a variety of product types, including sterile and non-sterile formulations. He also has 11 years of experience in manufacturing operations.
Tiffany Prentice, PhD
Analytical Chemistry Development
With a decade of experience in analytical chemistry, Tiffany is skilled in developing analytical methods and specifications for animal health products. Her expertise spans both physical and chemical methods, including HPLC/GC and MS, with a focus on impurity analysis and quality control. She also has extensive experience in CDMO troubleshooting and oversight.
Tom Mulhern, PhD
Drug Substance Process Development
With 37 years of experience, Tom specializes in drug substance process development, scaling processes from lab to manufacturing, and overseeing CDMO/CMO operations globally. His expertise includes optimizing processes for cost-effectiveness and regulatory compliance, along with cross-functional problem-solving.
John Masengale
Quality Control (QC) / Quality Assurance (QA)
With 40 years in QC and QA, John has extensive experience in testing, batch release, and deviation investigation. His background includes 14 years in corporate QA, with responsibilities in GMP audits and quality system development, ensuring high standards across production sites and consulting.
CMC Solutions: from targeted project need to full product development
We can help you with new product development, reverse engineering, reformulation of existing products and product line extension.
and Quality Assurance
Comprehensive management of CMO/CDMO relationships, ensuring seamless communication, supplier oversight, and alignment of development plans to meet quality, financial, and project milestones efficiently.
and Quality Assurance
Define an API manufacturing process that is safe, cost-effective, reproducible, and scalable.
Manufacturing Process
Develop and optimize the formulation and process from pilot to commercial scale while mitigating risks to reduce time to market and cost.
Manufacturing Process
and GMP Supplies
Develop and validate analytical methods and specifications to control starting materials, API, formulation excipients, and final product quality.
and GMP Supplies
Support throughout the entire regulatory process: including writing, advising, submission, following up with regulatory agencies, and overall oversight of global regulatory submissions.
Define the appropriate process validation strategy that precisely enables commercialization of the validation lots.
CMC Solutions: from targeted project need to full product development
We can help you with new product development, reverse engineering, reformulation of existing products and product line extension.
Comprehensive management of CMO/CDMO relationships, ensuring seamless communication, supplier oversight, and alignment of development plans to meet quality, financial, and project milestones efficiently.
Define an API manufacturing process that is safe, cost-effective, reproducible, and scalable.
Develop and optimize the formulation and process from pilot to commercial scale while mitigating risks to reduce time to market and cost.
Develop and validate analytical methods and specifications to control starting materials, API, formulation excipients, and final product quality.
Support throughout the entire regulatory process: including writing, advising, submission, following up with regulatory agencies, and overall oversight of global regulatory submissions.
Define the appropriate process validation strategy that precisely enables commercialization of the validation lots
Our support can optimize the drug approval process, because we offer
- Strategic project management to accelerate time to market.
- Optimization of CMC resources specific to project needs including formulation, drug substance, analytical, regulatory, and quality.
- Expertise in risk mitigation to ensure on time delivery.
- Tailored product solutions for the best market fit, optimizing dosage form to suit animal needs, manufacturing capability, and regulatory environment.
Interested in our CMC support?
Schedule a call, and we’ll answer your questions and discuss next steps.