OUTENIQUA
REGULATORY CONSULTING
Expert CMC regulatory support for complex product development and compliance
About Us
Outeniqua Regulatory Consulting is a scientific and regulatory consulting firm specializing in Regulatory and CMC, with deep experience in drug development and analytical sciences. We have experience across all stages of the development lifecycle, from preclinical development to post-approval lifecycle management.
We have deep expertise in cell and gene therapies, mRNA vaccines, antisense RNA therapeutics, biologics, and small molecules, with a strong track record in authoring and managing global submissions (IND, BLA, MAA, NDA) for sterile injectables, solid orals, and complex biologics.
CMC Consulting Services
Outeniqua Regulatory Consulting provides specialized CMC regulatory support for biotech and pharmaceutical companies developing complex products. We combine deep technical expertise with practical regulatory insight to help you move from early development to approval and beyond.
CMC Strategy & Risk Assessment
We design integrated CMC strategies that align development, manufacturing, and quality with global regulatory expectations. From target product profile to control strategy, we identify risks early and define clear, phase-appropriate plans.
CMC Dossier Authoring & Review
We author, review, and harmonize CMC sections for IND, IMPD, BLA, NDA, and MAA submissions. Our focus is on clear, consistent narratives and data packages that withstand agency scrutiny for biologics, ATMPs, RNA therapeutics, and small molecules.
We support CMC variations, supplements, and ongoing lifecycle management. This includes comparability strategies, change control support, and global alignment of filings to keep your products compliant as they evolve.
Post-Approval CMC Changes & Lifecycle
Our Advantage
Outeniqua Regulatory Consulting LLC provides precision-driven CMC expertise for biotech and pharmaceutical innovators. We navigate complex regulatory landscapes for advanced therapy medicinal products, ensuring your scientific breakthroughs meet stringent global standards.
Advantage
Advanced Product Expertise
Approach
Risk-Based Strategies
Performance
Proven Global Filings
Sustainability
Lifecycle Management
Proven Track Record
At Outeniqua Consulting, our impact is measured by the successful global authorization of life-changing therapies. Our track record reflects deep mastery in navigating the complex CMC regulatory requirements across multiple jurisdictions.
150
Global Filings
20+
Years of Experience
05
Complex Modalities
ALL
ICH Regions Supported
Modalities We Support
We partner with biotech and pharma teams across a range of complex modalities, providing focused CMC regulatory guidance from early development through commercialization.
ATMPs (Cell & Gene Therapies)
We help you navigate the unique CMC challenges of cell and gene therapies, from starting-material control and potency to long-term stability and comparability.
RNA Therapeutics (mRNA & Antisense)
We support CMC strategy for mRNA and antisense RNA products, including drug substance characterization, delivery systems, and robust analytical packages for global filings.
Biologics & Small Molecules
We provide end-to-end CMC support for monoclonal antibodies, recombinant proteins, and small molecules, ensuring coherent data, control strategies, and submissions across regions.
Meet Our Team
Our work is led by senior professionals with deep experience in complex biologics, ATMPs, and RNA therapeutics. Each engagement is handled by experts who understand both the science and the evolving global regulatory landscape.
Shaun Snyders PhD, Founder & Principal
Shaun is a global CMC regulatory leader with 20+ years of experience across biologics, cell and gene therapies, and RNA platforms. He specializes in end-to-end CMC strategy, dossier authoring, and lifecycle management for products targeting multiple regions.
Christine Voigt PhD, Clinical Consultant
Christine focuses on clinical strategy and agency interactions, with expertise in protocol development and strategy in alignment with the target product profile.