Clinical Trial Regulatory Services

Fewer Delays,
Faster Approvals

Caidya’s global regulatory services support end-to-end regulatory strategy, submissions, and life cycle management so you can move at the speed of science.

The Easiest Way to Meet
Regulatory Expectations

Across modalities and therapeutic areas, we serve as your interface with the U.S. FDA, EMA, and China CDE to reduce delays and drive practical execution from bench to clinical trial and market approval.

Sound Strategy

From regulatory strategy to life cycle planning, we give you the guidance you need to succeed across clinical development phases. We also prepare and lead health authority meetings, act as your global liaison with agencies, and manage documentation to enable clear, compliant, and efficient regulatory interactions.

Specialized Submission Expertise

Our team knows what to do and how to do it, whether we’re managing special designation requests, navigating novel programs with limited regulatory guidance, or supporting submission writing and preparation for investigational new drug (IND) and marketing applications across FDA, CDE, EU/Swiss agencies.

Impeccable Regulatory Operations

We take care of all regulatory operations, including:

Electronic common technical document (eCTD) publishing for FDA and CDE, ESG submissions
Document-level publishing
Life cycle maintenance, such as annual reports and amendments
Gov registration, updates, and establishment registration

… leaving you free to focus on innovating.

CMC and Nonclinical Support

Our regulatory and scientific experts work hand in hand to support chemistry, manufacturing, and controls, (CMC) strategy, writing, and project management.

We also offer nonclinical regulatory support including:

Study report review
Starting dose justification
IND-enabling strategy coordination

How Does Caidya Enable Global
Regulatory Success?

Whether in a global study, cross-border trial, or a combination, we:

Get You Meeting Ready

We support aligned, well-executed engagements with FDA, EMA, and CDE through:

Proactive advice meetings to shape regulatory strategy
Structured preparation
Standardized documentation
Clear timeline management

Deliver High-Quality Submissions, Every Time

We prepare complete, inspection-ready submissions that meet agency expectations and reduce review friction with:

Integrated scientific, CMC, nonclinical, and clinical inputs
End-to-end authoring, review, and dossier management aligned to evolving clinical trial regulatory requirements

Maintain Compliance at Every Step

Rest easy knowing that you’re always current, compliant, and inspection-ready with our timely:

Annual reports
Protocol amendments
Ongoing dossier updates

Support You in China and Beyond

With bilingual boots on the ground in China, we enable seamless English and Chinese communication and reduce time-zone barriers to deliver efficient, coordinated regulatory support worldwide.

Our regulatory team provides clear guidance and proactive insight that supports efficient development and helps bring innovative therapies closer to patients.

Susan Kong - VP Regulatory & Strategic Development

Our Clinical Trial Regulatory Services

Strategic regulatory consulting: Regulatory advice and guidance, regulatory intelligence and strategic assessments, clinical, CMC and nonclinical gap analysis, accelerated review pathway and guidance
Health authority meeting support: Preparation, leadership, and attendance for FDA, EMA, and CDE interactions, including INTERACT, Pre-IND, EOP1/EOP2, Pre-NDA/BLA, Pre-ANDA, scientific advice, and PIP/ODD/PRIME meetings
Regulatory submissions: End-to-end support for IND, NDA, BLA, CTA/IMPD, EU/Swiss MAA, DMF, and ANDA submissions with English/Chinese authoring and coordination; orphan drug designation (ODD), Breakthrough, Fast-Track, and other accelerated review application support
Regulatory operations: eCTD publishing for FDA and CDE, ESG submissions, document-level publishing, ClinicalTrials.gov registration and maintenance, and establishment registrations
Life cycle and file maintenance: Annual reports, IND maintenance including protocol, CMC, and nonclinical amendments, and ongoing dossier life cycle management across active programs
Inspection support: GCP/GMP inspection support

Put Our Regulatory Experience to Work

Our team of 50+ regulatory experts spans U.S., Germany, Switzerland, Taiwan, China, South Korea, Japan, Canada, and Europe, boasting a full spectrum of CMC, nonclinical, clinical pharmacology, and clinical expertise.

Whether you’re a small, virtual start-up, innovative drug development company, or anything in between, we anticipate requirements early and set you up for success with our experience supporting:

Submissions: We are experienced in managing IND, CTA/IMPD, NDA (505 (b)(1) and 505 (b)(2), BLA, DMF, ANDA, and MAA submissions, with over 1,000 electronic submissions per year
Special designations: We regularly manage special designation requests such as orphan, Fast Track, Breakthrough, rare pediatric disease designation, PRIME, pediatric plan, and priority review
Strategy and meeting coordination: We recommend and participate in strategic advice meetings in the pre-IND, end of Phase I, end of Phase II, pre-NDA/BLA, scientific advice, and special protocol assessment (SPA); we also support your clinical and marketing development strategy, due diligence, and provide regulatory intelligence and strategic assessments
Dossier and file maintenance: We maintain dossiers and files for over 80 active INDs annually, as well as multiple CTA, DMF, ANDA, NDA, BLA, and MAA files

Frequently Asked Questions About
Clinical Trial Regulatory Services

Which regions and health authorities do you support (US, EU, China, others)?

We support regulatory interactions across the FDA, EMA, and CDE, with capabilities aligned to major global health authorities and regional requirements.

What submission types do you handle (IND, CTA/IMPD, NDA/BLA, MAA, DMF/ANDA)?

We support end-to-end regulatory submissions, including IND, CTA/IMPD, NDA/BLA, EU/Swiss MAA, DMF, and ANDA, aligned to both development and marketing applications.

Do you support special designations and accelerated pathways (orphan, Fast Track, breakthrough, PRIME, pediatric plans, 505(b)(2))?

We support a range of expedited and special designations, including orphan drug status, Fast Track, Breakthrough Therapy, PRIME, pediatric plans, and 505(b)(2) pathways.

How do you prepare for and run health authority meetings?

We prepare, lead, and support health authority meetings such as FDA Type B meetings, EMA Scientific Advice, and CDE Type II meetings, using standardized preparation processes and structured timelines to promote readiness and alignment.

Can you publish and submit eCTD dossiers?

We provide eCTD publishing and submission support for the FDA and CDE, including ESG submissions and structured electronic dossier management.

How do you support lifecycle maintenance after initial submission?

We manage ongoing lifecycle activities, including annual reports, protocol and CMC amendments, and continuous dossier and file maintenance to keep submissions current and compliant.

Do you provide CMC and nonclinical regulatory support as part of regulatory services?

We provide integrated CMC and nonclinical regulatory support, including strategic consulting, gap analysis, and module authoring for regulatory submissions.

Can you support China–global bridging strategies and bilingual communication?

We support China–global regulatory bridging through bilingual English and Chinese communication and a deep understanding of China’s regulatory requirements alongside US and EU frameworks.

What types of products/modalities have you supported?

We have supported a broad range of modalities, including small molecules, biologics, vaccines, cell and gene therapies, and medical devices.

How do you work with small/virtual biotech teams?

We support small and virtual biotech teams by providing flexible, end-to-end regulatory support with strong cross-functional alignment, enabling fast, informed decision-making and efficient execution across development programs.