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:

 

The missions of our project managers

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).

Human behavior Behavior

 

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.

“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.”

Associated services

Program Management

Looking for peace of mind with outsourcing your regulatory projects and/or activities? BlueReg provides a tailored service with a continual monitoring and partnering with our experienced project managers to ensure a high quality of deliverables as per KPIs and metrics agreed at project initiation.

Associated services

Drug Registration and Regulatory Roadmap

BlueReg can be your preferred partner to support the registration of your medicinal product in Europe, in the US or in other worldwide countries. Our team of experts can also facilitate and guide clients through the process of formulating the roadmap, provide critical review of one or more elements of the roadmap, or provide hands on operational support through authoring some or all the components.

Associated services

Drug Registration

BlueReg can be your preferred partner to support the registration of your medicinal product in Europe, in the US or in export countries.

Associated services

SME representation

Looking for support of small to medium enterprise (SME) status in the European Union?  BlueReg coordinates SME client status dossier preparation and submission through its experienced project management team. BlueReg can also optimise the application content to expedite the approval by EMA

Associated services

Publishing & Submissions

BlueReg is your strategic partner to meet your goals in publishing activities and regulatory submissions worldwide. BlueReg provides a broad range of services for electronic Submissions (eSubmissions). You can rely on the BlueReg experienced team and efficient use of publishing and formatting tools to prepare your dossiers/documents according to Health Authority requirements. 

Associated services

BlueReg provides regulatory affairs outsourcing services to clients in a variety of ways tailored to their specific requirements.  It has such experience at its disposal that often it provides management consultancy to help clients review and / or design new business operating models.  BlueReg has developed a number of service platforms that support many clients in areas such as advertising and promotion, registration, life cycle management, or publishing and submission management.  BlueReg is proud to be able to provide references from its clients where new or expanded partnerships require it. 

Associated services

Export Countries

BlueReg is your strategic partner to meet your goals for all medicinal product registrations worldwide. BlueReg provides comprehensive regulatory affairs services, in global regulations and intelligence, across all regions of the world

Associated services

Early & Expanded Access Programs in France

Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs projects in France

Associated services

Exploitant Services

Looking for support in marketing your product in France? PharmaBlue, a BlueReg company, is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted a temporary use authorization (ATU) or a marketing authorisation (MA).


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