Who We Are
Our Vision
At eCTDConnection.com, we envision a future of rapid medical breakthroughs. We strive to make a positive impact on the lives of patients and their families through our efficient, cost effective submissions of your Essential Documents
Comprehensive eCTD Support
Cutting-Edge Technology
Cost-Effective & Time-Saving
expediting Medical Research to patient therapies
Essential Documents
The FDA requires certain regulatory submissions to be in the electronic Common Technical Document (eCTD) format. Here are the types of documents that must be submitted in eCTD format:
New Drug Applications (NDAs)
Abbreviated New Drug Applications (ANDAs)
Biologics License Applications (BLAs)
Investigational New Drug Applications (INDs)
Master Files (MFs)
Drug Master Files (DMFs)
Annual Reports
Amendments
Supplements
Meeting Requests and Correspondence
Adverse Event Reports
The eCTD format helps streamline the submission, review, and lifecycle management of applications, ensuring consistency and ease of access for regulatory authorities.
Comprehensive eCTD Support
From initial planning to submission, our team provides end-to-end support to ensure your dossiers are complete and compliant.
Expert Regulatory Knowledge
Our professionals are up-to-date with the latest global regulatory requirements, ensuring your submissions are accepted the first time.
Our professionals specialize in analytical, clinical, regulatory, and compliance affairs specific to FDA/ICH (GMP/GLP/GCP/QSR/ISO) Regulatory and Compliance requirements in the Biological, Pharmaceutical, and Medical Device Industries.
Cutting-Edge Technology
Utilize our state-of-the-art software that simplifies eCTD submissions, offering real-time tracking, validation, and troubleshooting.
Customized Solutions
We tailor our services to fit your specific needs, whether you are a small biotech company or a large pharmaceutical enterprise.
Cost-Effective & Time-Saving
With our efficient processes, you can reduce overhead costs and shorten the time to market, giving you a competitive edge.
Collaborative Approach
We believe that the best results come from working together. That's why we collaborate with other research institutions, medical centers, and pharmaceutical companies to achieve our goals.
Innovative Solutions
We're always looking for new and innovative ways to approach medical research. Our team is constantly exploring new technologies, techniques, and approaches to achieve our goals.
our services
eCTD Submission Preparation
Ensure all documents are formatted correctly and compliant with agency guidelines.
Lifecycle Management
Manage updates, changes, and sequences throughout the product’s lifecycle .
Validation & Quality Control
Comprehensive review and validation checks to avoid costly delays.
Country Specific Regulatory Consultancy
Expert advice on global submission strategies and requirements.
USA, South East Asia, Armenia, Australia, Austria, Poland, India, Indonesia, Slovenia, Germany, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China Croatia, Denmark, Egypt, Estonia, Finland, France, Greece, Hong Kong, Hungary, Ireland, Isle of Man, Italy, Jordan, Republic of Korea, Latvia, Liechtenstein, Lithuania, Luzembourg, North Macedonia, Malaysia, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Puerto Rico, Romania, Soudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Taiwan, Switzerland, Thailand, Turkey, United Kindom, and United Arab Emirates.