Services:    Submissions    |    Document Management    |    Organization    |    Collaboration

Aerie Canal offers a wide range of Regulatory Operations consulting services, tailoring each project to meet our clients' unique needs and product development cycles. Services range from developing document management solutions to preparing an organization to support a company's first marketing application; from submission project management and publishing to developing solutions for partner interaction and due diligence.

Electronic Submissions

With proper planning and groundwork, successful submissions do not require last minute scrambles and overtime. Aerie Canal can help you deliver electronic submissions on time, on budget, and with less stress.

The bulk of the work is done during the authoring process. Creating documents from templates, inserting tables correctly, and following company style guidelines are key elements to reducing publishing timelines.

It is the role of Regulatory Operations to lay the foundation for this approach very early in the process and to support authors throughout the entire document development and review process. It is essential to meet with key groups early on to establish standards for every document type and define clear processes for document handoff.

Whether a team is working on a company’s first marketing application, or a line-extension for a blockbuster product, each project is a new challenge that requires matching the team, the technology, and the process to deliver a quality submission.

With the advent of eCTD, smaller companies can now create electronic submissions with minimal overhead. The Electronic Submissions Gateway enables any company to deliver submissions over the web so that FDA reviewers receive them the day they are published. The barriers to entry have never been lower for electronic submissions.

Document Management

Because documentation needs to be accessible for regulatory research and inspections for the life of the product, Document Management is one of the most important aspects of Regulatory Operations.

Your project’s success depends on making the right decisions early in the process, such as selecting a system and vendor, and agreeing on key requirements.  Traditional big pharma solutions may be overkill for small companies.  Aerie Canal Consulting can help you choose a solution that fits your existing IT architecture, while allowing for anticipated growth.

Aerie Canal Consulting can help you find the right Document Management Solution for your company.

Organization

Regulatory Operations organizations must be flexible enough to meet a company’s needs during all stages of product development, and robust enough to deliver quality submissions on deadline. This balancing act requires strategic planning to align Regulatory Operations with the trajectory of the organization.

Regulatory Operations staffing and strategy depend on the size and needs of your company, and can include a mix of the following approaches:

  • Hiring the right-sized staff for the organization
  • In-sourcing experienced publishers for key projects
  • Using software as a service (SaaS) solutions to avoid IT overhead
  • Training existing administrative staff to support submission formatting
  • Outsourcing submissions

Aerie Canal Consulting can help your Regulatory Operations organization develop the right strategy for success.

Collaboration

Drug development is a globally dispersed activity, with partners, affiliates, and vendor organizations collaborating across time zones. Even the best technology can’t prevent time differences, conflicting IT policies, and dissimilar corporate cultures from getting in the way of effective collaboration. Regulatory Operations organizations play a key role in linking collaborators through common technology and processes.

Partner activity often includes due diligence, which relies on documentation managed by Regulatory Operations. Aerie Canal can help you set up internal systems to support due diligence, and use virtual data rooms to ease the burden of preparing for and monitoring diligence activities.