Human Health Regulatory Services
Our Human Health regulatory solutions are designed to guide sponsors from early development through post-approval maintenance, ensuring smooth and compliant regulatory pathways.
IND, ANDA & NDA Strategy
We offer strategic regulatory planning for Investigational New Drug (IND), Abbreviated New Drug Application (ANDA), and New Drug Application (NDA) submissions. Our approach focuses on optimized submission strategies, regulatory risk assessment, and alignment with FDA expectations to improve approval success.
Pre-Submission Meeting Support
We assist clients in preparing for and managing FDA pre-IND, pre-NDA, and pre-ANDA meetings. This includes briefing document preparation, question framing, regulatory gap analysis, and post-meeting action plans to ensure clarity and alignment with regulators.
eCTD Dossier Preparation & Review
Our team specializes in electronic Common Technical Document (eCTD) preparation, publishing, and quality review. We ensure dossiers are compliant with current regulatory standards, technically sound, and submission-ready for global health authorities.
FDA Deficiency Response & Remediation
We provide expert support for responding to FDA queries, information requests, and deficiency letters. Our services include root-cause analysis, remediation strategy development, and preparation of scientifically robust and compliant responses.
Post-Approval Changes & Lifecycle Management
We manage post-approval regulatory activities, including supplements, variations, labeling updates, and change management. Our lifecycle management solutions help maintain compliance while supporting product growth and market expansion.
Veterinary Health Regulatory Services
FDA-CVM Submissions (NADA / ANADA)
Biowaiver & Bioequivalence (BE) Strategy
Biowaiver & Bioequivalence (BE) Strategy
We provide end-to-end support for New Animal Drug Applications (NADA) and Abbreviated New Animal Drug Applications (ANADA), including regulatory strategy, dossier preparation, and submission management.
Biowaiver & Bioequivalence (BE) Strategy
Biowaiver & Bioequivalence (BE) Strategy
Biowaiver & Bioequivalence (BE) Strategy
Our experts develop biowaiver and bioequivalence strategies for veterinary products, ensuring scientifically justified approaches that meet FDA-CVM regulatory expectations and reduce development timelines.
Target Animal Safety & Residue Study Support
Target Animal Safety & Residue Study Support
Target Animal Safety & Residue Study Support
We assist with regulatory planning, protocol review, and documentation for target animal safety studies and residue depletion studies, ensuring compliance with animal welfare and food safety regulations
Labeling & Regulatory Compliance
Target Animal Safety & Residue Study Support
Target Animal Safety & Residue Study Support
We support the development and review of veterinary product labeling, ensuring accuracy, compliance, and alignment with FDA-CVM requirements, including claims, usage directions, and safety statements.
Why Choose Us?
- Proven regulatory expertise across Human & Veterinary Health
- End-to-end support from development to post-approval
- Strong understanding of FDA & global regulatory requirements
- Strategic, compliant, and cost-effective solutions