Project Management

Understanding client needs and scoping the journey ahead.

Project Management Framework
  • Our Project Management team has built a framework that will set, maintain, and ensure the highest standards are achieved to make your innovative inhalation project a success.
  • Our Project Managers have a broad range of technical backgrounds and hands-on project experience, meaning we will work with you to create and develop effective strategies. This approach delivers value to your business, ensuring your products reach the market safely, on time and aligned with budget.
A Tailor-Made Service

A Tailor-Made Service

Project Initiation

Project Initiation

Strategy Definition

Strategy Definition

Compilation

Compilation

A Tailor-
Made Service

At Broughton, we go that extra step. Having delivered successful regulatory projects for a range of clients, we use this experience to effectively plan projects and support our clients through the relevant regulatory pathway. A dedicated Project Manager will be your single point of contact right from project initiation, through to regulatory submission and beyond. Clear deliverables for each stage of the project will be agreed, with communication pathways being followed throughout. Our Project Management team have standardized practices and methodologies in place. However, we understand the reality that no two projects are the same. We therefore follow an agile and flexible approach to your project and have the know-how to create tailored solutions that meet the specific requirements of your project.

Project Initiation

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 deliverp ables, 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.

Strategy Definition

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 deliverp ables, 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.

Compilation

During this phase, we work with you to generate the data and relevant documentation that is required for your regulatory submission. Your Project Manager will manage and control the multiple workstreams, executing the various studies, reports, data reviews, and audits that are vital in demonstrating that your product is compliant in its desired market.

Contact us

From basic questions to complex compliance inquiries, we're here to help! Contact us today.