Submission management and expertise for life science companies

Submission management

Experienced project management is key for a successful submission. The project manager is responsible for working with the submission team to build a realistic timeline with documented estimates. It is of the essence to keep stakeholders informed of what is achievable within a given timeline, while adapting to any unforeseen changes.

Our consultants have the experience and skills to lead you through a seamless submission process.

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Keys to successful submissions

Arex provides a submission manager who is responsible for driving communication within the organisation, striving for alignment within the team to ensure accountability, adhering to target timelines, and ensuring adequate resources to support the entire submission process.

Among the contributing factors of successful submission management are:

  • Document management: predefined templates, client specific templates, rigorous version control, change control, quality control.
  • Identification of, and collaboration with key subject matter experts early in the process
  • Coordination and monitoring of timelines
  • Risk management and risk mitigation
  • Ability to adapt to any changes in regulatory requirements
  • Successful and realistic time management
  • Experienced medical writers

CTIS Submission
According to EU ors will have to submit their applications online through the Clinical Trials Information System (CTIS), which is the single-entry point for submitting clinical trials in the EU.  Submission management in CTIS requires education and adherence to updates in the CTIS portal.

IRIS Submission
The IRIS (Innovation and Regulatory Science) platform is the (EMA) online submission system for applications related to orphan designation, PIP (Pediatric investigation plan) and PRIME (PRIME eligibility request), scientific advice, and marketing status reporting. It streamlines communication between applicants and the EMA, ensuring structured handling of regulatory submissions.

Efficient submissions in IRIS require experience from navigating the system, managing the pre-defined timelines and documents, and communication channels within the system.

eCTD Submission

eCTD is the global standard for submitting regulatory documents to health authorities. Arex provides timely and cost-efficient eCTD submissions together with our partners, ensuring a smooth and compliant process.

Why use our support with submission management?

Arex has a transparent approach to submission management, with a close collaboration between our project/submission manager and your project manager. This setup provides stable support, built on trust and ability to take immediate action when changes occur.

We ensure compliance, with a strong focus on:

  • Proper management of your submission documents
  • Adherence to country-specific requirements for submission
  • A clear regulatory strategy
  • Avoiding delays or rejections
  • Time savings
  • Minimising costs and efforts
Your contact person
Portrait of Erik Hedner Arex Advisor

Erik Hedner

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.