Commercialisation

Commercialisation

In many situations we are engaged with clients throughout product development and the registration process. This continuity of relationship builds a deep understanding of the product and future strategy with the rollout to market. But this is not always the case and clients approach us during first registration to help with launch activity and to plan for future management of their product across the World.

 

The challenges faced largely result from not having the expertise in house but often the ability to manage high peaks and troughs coming from commercial launch decisions. The ability to scale activity in one or markets is highly important to reaching Healthcare Professionals (HCP) and patients alike in a timely fashion.

 

Once the product is approved consideration must be given to managing the product in an organised and cost-effective fashion. We provide management consultancy to guide clients in the design of a future operating model to support a commercial operation and, if required, we can support an outsourcing service accordingly. We are able to act as Exploitant in France for commercial products or advise clients in how to setup themselves.

Drug

Time to engage with BlueReg

It is important to be able to makes decisions based on all the available input and data. Therefore, the sooner a project can be shared to obtain our input the better. Our experience with other client activities can provide valuable insight to the challenges ahead. Regulatory roadmaps are developed in a similar manner to Target Product Profiles with the end in mind and regularly scrutinised and developed as more data become available.

Regulatory submission planning is a team effort with multiple inputs and stakeholders.  It is preferable to develop the regulatory submission strategy early and implement a tactical action plan to ensure that deliverables are met according to expectations.  Early investment in time pays dividends in the overall project timelines as it ensures all stakeholders are driving towards the same goals with the same set of assumptions.

 

Commercialisation and the time to engage with BlueReg

Clients rely on our regulatory intelligence as well as the experience and expertise of our consultants for the success of their project. We can provide you with an end-to-end project plan to guide you from the development of your product right through to authorisation and beyond. Some of the services we offer include:

  • Regulatory, medical & legal review and validation of advertising and promotional materials at global & local level (e.g. worldwide services as per local requirements (e.g. ABPI signatory in the United Kingdom, Information Officer in Germany, Regulatory Scientific Services in Italy, Responsible Pharmacist in France…)
  • Provide advice on the validation workflow, through the choice, configuration and implementation of an adapted software along with the writing and review of related SOPs
  • Provide training on promotional material review and validation requirements (e.g. for global or local requirements)
  • Interaction with healthcare professionals
  • Compliance of the interaction with HCPs (DMOS), assistance in the certification of sales representatives
  • Manage SmPC, PIL/PI, labelling updates
  • Exploitant services including acting as the Responsible Pharmacist, assistance and advice with obtaining “Exploitant” status, audits, preparation of client-customized SOPs, provision of deputy QPs (PRI)
  • All stages of life cycle management activity including annual reviews, supplemental updates, variations (administrative, safety, CMC etc.), renewals, license transfers, management of post-approval commitments
  • CMC and safety compliance: gap analysis between approved pharmaceutical parts or clinical parts and reference documents and to set-up the appropriate strategy to upgrade the corresponding part of the file
  • Advice online extension, legal switch application, inform consent file, …
  • Support for the process of linguistic review and other translations

Once the product is approved consideration must be given to managing the product in an organised and cost-effective fashion. BlueReg provide management consultancy to guide clients in the design of a future operating model to support a commercial operation and, if required, we can support an outsourcing service accordingly.