Commercialisation & Launch

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 by our clients 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-DEV-CONSULTING

Clients rely on our regulatory intelligence as well as the experience and expertise of our consultants for the success of their project

 

 

The time to engage with BlueReg

Commercialisation planning and execution is paramount to a timely launch of the product in the concerned market. This group of activities requires a team of specialists that follow a detailed plan and the regulatory roadmap. There is a great deal of resource required in a short space of time and clients look to BlueReg to ramp up capability and capacity in quick time. Developing a team approach involves determining a clear set of roles and responsibilities.

 

To execute a timely product launch the management of the final registration package is key so that there is no delay in the administrative elements such as provision of the approved labelling, and translated documentation in order, and confirmation of any post approval commitments.

 

BlueReg is well known for Advertising and Promotional copy review during the launch phase. We provide experts in their field, well used to managing local codes of practice and manging activity in local language and in client systems such as Veeva®, Trackwise® and so on. We manage and coordinate activity to ensure a consistent approach across markets so that a practical level of feedback is provided and in a consistent manner.

Commercialisation & launch component services

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
DRUG-DEV-CONSULTING

“Thank you very much to you for your always efficient work and your close monitoring of regulatory developments. Totally shared pleasure!”