eCTD SUBMISSION MANAGEMENT SERVICES

REGULATORY OPERATIONS TO SUPPORT eCTD SUBMISSIONS

ONIX supports Pharmaceutical, Biotechnology, Contract Research Organisation and Pharma Venture Capital companies with their eCTD submissions to global regulatory health authorities.

We have extensive experience in submitting eCTD’s to EMA, MHRA, FDA, Health Canada, Swissmedic, Australia, ASEAN GCC, SAHPRA/MCCZA and EAEU and Rest of World.

eCTD SUBMISSION MANAGEMENT SERVICES

ONIX is a leading provider of eCTD regulatory submission. We simplify the process for our clients by providing expert advice and delivering compliant submissions. We pride ourselves on delivering an exceptional customer experience that exceeds our clients’ expectations. Focus on building a mutual trust with our clients is evident in everything we do, from providing clear and concise advice to delivering high-quality submissions that meet all regulatory requirements. Our clients know that they can rely on us to provide consistent high-quality service.

ONIX supports clients with eCTD Submission Strategy, Project Management, eCTD Compilation, MS Word formatting, PDF publishing, QC Review, Technical Validation, Submit via Gateways and continue eCTD Lifecycle and Submission Webviewer Hosting.

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1. Project Management

eCTD Strategy

Timelines

eCTD Metadata content plan management

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2. eCTD Submission

Word formatting

PDF publishing

eCTD compilation

Bookmarking

Hyperlinking

QC Review

Client Review & Approve

eCTD Validations

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3. Submit via Gateway

Upload submission

Receipt of submission

Submission archive

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4. eCTD Lifecycle Submission Management

eCTD Lifecycle continues

eCTD Submission Expertise

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PROJECT MANAGEMENT

Project Management is key for a successful eCTD submission, advising on strategy and creating a content plan to track the timelines for the project deadline to be met, and to make the eCTD submission a success.

Our goal is to ensure that all submissions are done in a timely and efficient manner. To achieve this, we work closely with our clients from the very beginning to ensure that they have all the necessary information and resources. We believe that a true partnership is the key to a successful submission, and we are committed to providing our clients with our proven eCTD management service.

The journey begins:

  • Strategy for the eCTD application
  • eCTD Metadata
  • Single shared eCTD content plan
  • Roles and responsibilities
  • Systems for exchanging documents
  • Schedule submission team meetings

eCTD SUBMISSION

Plan in place, the eCTD work begins with our clients providing documents for the submission, these can be either provided as Word or PDF.

eCTD Compilation

As eCTD experts, we are responsible that all documents meet the requirements of the ICH and Regional health authority. We analyse each submission for compliance with the guidance requirements and the final eCTD.

Our varied technologies and our strong understanding of the eCTD requirements enable us to process submissions efficiently to ensure each submission is compliant.

We provide a high quality service that meets the needs of our clients. We are proud of our reputation as a leading provider of eCTD services. We follow a consistent approach for all eCTD submissions:

  • eCTD Compilation of files
  • Hyperlinking of files
  • eCTD validation
  • Client review and approve of eCTD Submission
  • Validate and submit to Regulatory Health Authority
  • Archive
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eCTD GATEWAYS

Electronic Submissions Gateway is a transfer portal; a digitally secure environment for eCTD submissions to be uploaded to the regulatory health authorities. ONIX have setup gateways to submit to FDA, EMA, MHRA, CESP and Portugal Portal.

  • Europe – EMA, MHRA and CESP
  • USA and Health Canada – FDA Gateway
  • Portugal – INFARMED

eCTD LIFECYCLE MANAGEMENT

We understand that our clients need to submit regular updates with short deadlines. We respond quickly and efficiently to requests for eCTD lifecycle submissions. To date we have never missed a client deadline. We work with a wide range of global clients, providing support throughout the entire drug submission process from Phase I to Phase IV. We are often requested to take over eCTD submissions partway through their lifecycle, and we make the transition quick and seamless so that there is no interruption in the submission process. We are highly experienced and knowledgeable when it comes to importing applications and continuing lifecycle.
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eCTD Submission Expertise

We have extensive experience and expertise global submissions, offering a full range of services, from pre-submission planning to post-submission support. We keep up to date on the latest submission requirements and procedures.

We offer comprehensive support for submission types, including:

  • Europe – Centralised, Decentralised, Mutual Recognition, National Procedures, ASMF, CTA and PIP Submissions
  • USA – IND, NDA, aNDA, BLA (CRFs and Dataset) and DMFs
  • Swissmedic
  • Health Canada
  • Australia
  • ASEAN, GCC, SAHPRA/MCCZA, EAEU, Thai-FDA and Rest of World
  • China and Jordan

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