Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
September 20, 2025
Approximately 5 minutes
The Path to Approval: Navigating the New Drug Application (NDA) Journey
The Path to Approval: Navigating the New Drug Application (NDA) Journey
Bringing a new drug from the laboratory to the patient is a highly structured and regulated journey. The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.
Step 1: Preclinical Studies
Before a drug is ever administered to a human, it must undergo rigorous in-vitro and animal studies. These studies evaluate pharmacological activity, toxicity profiles, and pharmacokinetics (ADME—Absorption, Distribution, Metabolism, and Excretion) to establish an initial safety rationale.
Step 2: Investigational New Drug (IND) Application
If preclinical results are promising, the sponsor submits an IND. This application includes preclinical data, manufacturing information (CMC), and clinical trial protocols. Approval of the IND is the green light required to begin testing in humans.
Step 3: Clinical Trials (Phases I–III)
The clinical phase is the most resource-intensive part of the journey:
- Phase I: Focused on safety, tolerability, and PK in a small group of healthy volunteers.
- Phase II: Focused on dose optimization and efficacy in a target patient population.
- Phase III: Large-scale trials to confirm safety and efficacy across diverse populations.
Step 4: CMC and Quality Documentation
The NDA must provide a complete picture of the drug’s "identity." This includes detailed manufacturing processes, analytical methods for quality control, stability data to determine shelf life, and proof of General Manufacturing Practice (GMP) compliance.
Step 5: The NDA Submission (CTD Format)
The application is organized using the International Council for Harmonisation (ICH) Common Technical Document (CTD) structure:
- Module 1: Administrative information and prescribing labeling.
- Module 2: High-level summaries of all technical data.
- Module 3: Quality (CMC) details.
- Module 4: Nonclinical study reports.
- Module 5: Clinical study reports.
Step 6: FDA Review and Approval
During the review phase, the FDA evaluates the risk-benefit profile, inspects manufacturing facilities, and finalizes the drug’s labeling and indications. An approval letter signifies that the drug has met the highest standards of safety, efficacy, and quality, allowing it to be commercially marketed.
The NDA process is the ultimate safeguard of public health, ensuring that scientific innovation is always balanced with patient safety.