Understanding client needs and scoping the journey ahead.
In order to align with your business goals and needs, a dedicated Project Manager will work with you to clearly understand the project scope and deliverables. The project may be broken down into allocated scopes of work giving full visibility of project gateways and budget spend.
We start with a project charter mapping out clear deliverables, followed by a request for information (RFI). Our process has been developed to ensure all prerequisites for your regulatory submission are met. We complement this with secure cloud storage of your information.
Your information is reviewed which may involve a gap analysis to understand what work is required to meet the necessary regulatory requirements.
Finally, we will agree a communication plan with your team and establish regular meetings to ensure your project remains on track.
The strategy definition phase is where the Broughton project team gather and review all the necessary information required for your NGP regulatory submission. We have the knowledge and experience to understand what is required for your regulatory submission and each workstream within the project is assigned a lead who is a subject matter expert (SME).
Your Project Manager is responsible for ensuring that workstream milestones are met. They work closely with our extensive network of SMEs to design appropriate studies and identify the necessary data to achieve a successful regulatory submission. We work with both internal and external SMEs to optimize time and costs.
Project costs and timescales will be clearly defined and communicated following the strategy definition phase.
We understand that each submission is unique. Data generated during the compilation phase, along with scientific narratives, are channelled through our workstream leads and compiled into a dossier. The dossier is submitted via the prescribed processes to aid regulatory review in support of submission success.
After the dossier is submitted, the regulatory body will review and analyse the data and narratives to determine if the product meets regulatory requirements. During this review period, the regulatory body will often ask questions where further clarification is needed or request additional data to support the submission. Our project team will be on hand to ensure that any queries are acknowledged, actioned, and addressed in a timely manner to complete the project.
From basic questions to complex compliance inquiries, we're here to help! Contact us today.