Outsourcing Programs

BlueReg has developed a unique methodology to support your projects when complete or partial outsourcing is required along with appropriate project management tools.

 

Outsourcing engagements typically concern the following:

  • European & US registrations
  • Worldwide geographical rollout (OPREC)
  • Lifecycle management, launch and Early access programs (OPPARS)
  • Promotional material review (OPPROS)
  • Publishing (OPPUS)

For any of these activities, a BlueReg Project Manager will be assigned to your project as key contact point person along with a dedicated team of highly experience BlueReg consultants specialised in regulatory affairs, scientific writing or publishing.

 

A tailored service with a continual monitoring will be set up by the Project manager to ensure a high quality of deliverables and respect of timelines as per KPIs and metrics agreed at the project initiation. Long relationship is key for such a project and BlueReg focus will be to maintain smooth transition between all steps of the project and ensure that roles & responsibilities are clear for all stakeholders (RACI).

 

The values of BlueReg, Integrity, Team Spirit, Commitment, and Agility,  are engendered by the staff we employ.  The fact that many originate from similar pharma companies as our clients means there is an inherent understanding of the pressures and constraints that are faced and working relationships are collaborative and rather ‘un-consultancy’ like.

 

Outsourcing and the time to engage with us

In recent years, the industry has seen a significant increase in outsourcing activity. The decision to outsource is made often in the interests of lowering costs, redirecting or conserving energy directed at the competencies of a particular business, or to make more efficient use of resources. Its aim is to help companies achieve their business objectives through operational excellence.

 

With something of an unpredictable starting point, normally based around an event or acute need, clients value BlueReg’s experience and established platforms for key elements of support.  There is comfort from knowing that this isn’t the first time that BlueReg will have carried out such outsourced services.  That said, it is also of value to our clients that we do not consider a ‘one size fits all’ approach.  Our team has experience from a wide variety of professional service environments and this enables the opportunity to really understand and construct a pragmatic and working model that works for that given situation.

 

Of course the time to discuss such outsourcing services is as soon as possible particularly as, sometimes, detailed planning and preparation time is required to ensure future success.  However, we aim to support our clients in whatever circumstances are presented and develop a trusting collaboration. 

Outsourcing and component services

BlueReg delivers its services based on a platform approach.  BlueReg provides comprehensive regulatory affairs services, in global regulations and intelligence, across all regions of the world, supported by the expertise of our consultants and our international qualified partners.

 

BlueReg support companies in registration roll out in ICH and non-ICH regions by providing advice and regulatory support on the various steps of regulatory plans.

This includes:

  • European & US registration strategy, support, and scientific writing  
  • Global CMC business solutions for Pharmaceutical Development, CMC Regulatory Affairs & CMC Project Management, supporting clients through the lifecycle of medicinal products (small molecules, peptides, biologics, ATMP), medical devices and consumer health care products.
  • Worldwide geographical rollout based on a methodology called Outsourcing Platform on Registration for Export Countries
    “OPREC” (OPREC) managing core ICH region dossiers and the tailored adjustment for submission in other locations.  
  • Lifecycle management, launch and Early access programs managed through BlueReg’s Outsourcing Platform on Post-Authorisation Regulatory Services “OPPARS”.  
  • Promotional material review is facilitated through the Outsourcing Platform on Promotional Material Services “OPPROS”.  BlueReg provides a broad range of services linked to the review of promotional material for international congresses and local compliance.
  • Outsourcing Platform on PUblishing & Submission Services “OPPUS” enables BlueReg to provide a broad range of services for electronic Submissions (eSubmissions). These include publishing
    Expertise (eCTD, NeeS and Paper Formats), document compliance, and gateway submissions.
  • BlueReg (PharmaBlue) provision of ‘Exploitant’ services to companies looking for a partner to launch their products on the French market and can take over the organization and supervision of the distribution in France of pharmaceutical products, including advertising, information, pharmacovigilance, batch follow-up, and if required, batch withdrawal operations.
BG__0000s_0008_DOCUMENTS

“Thank you so much for your support to date.  BlueReg has been a great partner. I like the proactive approach for feedback and you have been extremely helpful and are very thorough. Looking forward to our continued partnership.”