Regulatory Guidance
Bridging Innovation and Regulatory Success
Scientist-led and regulatory savvy, we guide you through IND, CMC, ICH, FDA, and ISO challenges to guarantee a smooth path to market.
Navigating regulatory pathways is one of the most challenging aspects of drug development.
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Whatever level you may be on, ensuring compliance while accelerating development is critical to your success.
We help companies navigate the bringing a drug to market and achieving FDA compliance through our U.S.-based operations.
Who We Support
Universities & Research Institutions
We aid in translating academic discoveries into real-world therapies by guiding the process from preclinical research to IND submissions. Our team helps bridge expertise gaps and align preclinical study designs to meet FDA and EMA expectations for novel or first-in-class therapies.
Startups & Emerging Biotechs
We help identify the right regulatory pathways (IND, NDA, BLA, 510(k), etc.) and build regulatory roadmaps that align with your funding and commercialization goals.
Drug Manufacturers
Our services focus on streamlining GMP compliance for pharmaceutical production and implementing quality control systems to meet evolving standards.
Technical Regulatory Services
FDA Registration Support
Following ICH FDA guidance, we assist with process validation, method validation, forced degradation, and fate of impurity investigations for registration batches.
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CMC Regulatory Activities
We support Chemistry, Manufacturing, and Controls (CMC) activities, including stability studies, accelerated stability testing, batch records, and Module 3 authoring.
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Medical Device Compliance
We provide guidance for Liquid Medical Devices, including both FDA 510(k) and DeNovo Registration per 21 CFR 820.
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Dossier Compilation
Our PhD-led regulatory department provides expert writing and compilation for IND, NDA, BLA, and 510(k) filings, as well as FDA meeting preparation.