OUR SERVICES

Submission Software Installation & Systems Validation Services

VECTOR offers a range of software to support your regulatory needs. Our technical expertise includes years of experience working with pharmaceutical companies in Africa, implementing systems to transition customers from a paper based process to electronic submissions.

We will advise you on your setup and assist you in the installation and validation of your new submission systems.

eSubmission and Software Training & Industry eCTD Workshops

Whether it is software training for regulatory information management, submission compilation, submission validation or submission tracking, VECTOR offers the training you will need to make the most out of your software implementation.

With years of experience with electronic submissions, our training expertise is often shared in industry workshops with practical hands-on exercises.

Technical Systems Setup, SOP Development & Transitional Consulting for Electronic Submissions and Processes

Our consulting expertise goes back to working with customers transitioning from paper based processes to electronic submissions when eCTD was first introduced in the U.S., Canada, and the EU in 2002. We at VECTOR know what to look out for, what to plan and how to make the most of moving to an electronic based submission process.

We have assisted companies throughout the world develop processes and SOPs to ensure the switch to their new processes is smooth and easy.

OUR INDUSTRY OFFERING

DOCUMENT PREPARATION

Are your documents CTD/eCTD ready?
Prepare future oriented documents conform to current and future standards and ready for reuse across multiple applications.

DOCUMENT MANAGEMENT

Are you conforming to the new ISO requirements for data storage?

Manage and maintain your regulatory documents in a document management system providing data security, access control and version control.

SUBMISSION MANAGEMENT

Are you spending too much time preparing your applications?
Compile and maintain your regulatory applications efficiently taking advantage of content re-use by cloning, merging and replicating content from one application to another. NEVER COMPILE ANYTHING TWICE. Automatically create paper volumes with table of contents (TOCs), tab sheets and consistent header and footers across all documents. Be future oriented and create dossiers today that can be used electronically tomorrow e.g. for eCTD and RPS.

SUBMISSION VALIDATION

Are your applications conform to technical specifications?
Validate your applications and ensure they pass technical validation at agencies with electronic validation criteria.

APPLICATION TRACKING

Are you on top of all your registrations?
Track all your regulatory activities and registrations in all of your markets in a secure environment. Manage your upcoming tasks and alerts, create management reports on the fly and never miss another deadline.

TRANSITION CONSULTING

Are you ready for your electronic regulatory systems?
Ensure you do not overlook any aspects of moving from paper based methods to electronic processes. Let our experience help you along the way.

OUR AUTHORITY SERVICES

SPECIFICATION DEVELOPMENT

Are your application specifications clearly defined?
Create clear guidance for Industry on the structure and format of their applications both in paper and electronic formats. Whether going eCTD or Electronic CTD or implementing electronic guidance for other formats e.g. Veterinary, Medical Devices, etc., be sure industry knows what you want through technical validation criteria. You will make your evaluations more consistent and enable more predictable review times through clearly developed specifications.

SUBMISSION VALIDATION

Are your applications conform to technical specifications?
Validate incoming applications and ensure they pass technical validation. Validation not only can check the application setup and document compliance, it can automate the initial screening process to ensure all the documents for a particular submission type have been provided.

SUBMISSION EVALUATION

Are you spending too much time preparing your applications?
Manage the application evaluation assignments and control access with a fully validated system. View applications over time with easy access to past data to improve evaluation quality. Annotate and comment directly in the applications without disrupting the delivered documents and export comments for use in expert reports. Ensure accountability through audit trails that will document all access and changes within the system.

DOCUMENT MANAGEMENT

Are you conforming to the new ISO requirements for data storage?
Manage and maintain your evaluation reports and applicant correspondence in a document management system providing data security, access control and version control.

APPLICATION TRACKING

Are you on top of all your evaluation activities?
Track all your registrations, regulatory activities and evaluation status for all your product categories e.g. Chemical, Biological, Prescription, OTC, Complementary, Veterinary, Medical Devices, DMFs, Clinical Trials, etc. Have a clear overview of activities via interactive dashboards and extract reports effortlessly.

TRANSITION CONSULTING

Are you ready for your electronic regulatory systems?
Ensure you do not overlook any aspects of moving from paper based methods to electronic processes. Let our experience help you along the way.

FAQ

Frequently Asked Questions

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