Product Development

At BlueReg we share the passion for the development process and are motivated by the prospect of helping others with new products (pharmaceuticals, advanced therapies or medical devices) or therapeutic indications. 

 

Product development to BlueReg means setting out a regulatory roadmap, a pathway towards approval in the target market and target therapeutic indication. It means helping clients navigate through the process of discussing their projects and challenges with regulators through Health Authority meetings, and lastly in this section, preparing a regulatory application dossier (New Drug Application or Marketing Authorisation Application) that showcases the intention of the applicant. All of which is not just about strategy but hands on support to write and prepare the regulatory submissions.

 

 

Our consultants have come from similar environments as our clients
and have ‘walked in their shoes’.  As a result, the working relationship during such projects is special and there is real collaboration between consultants and client stakeholders, thus blurring the lines between client and service provider.

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.

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Associated services

Advanced Therapy Medicinal Product (ATMP)

Looking for an Advanced Therapy Medicinal Product (ATMP) classification? BlueReg can guide you to submit a classification application to Health Authorities to determine if your product meets the requirements to be defined as an ATMP.

Associated services

Drug Development Consulting & Strategy

Currently developing a new medicinal product ? BlueReg can provide an end-to-end project plan to guide you from the development of your medicinal product right through to authorization and beyond.  We can provide advice and recommendations to ensure the shortest time to market by minimising any possible barriers during the development process and beyond.

Associated services

CMC Product Development

Looking for Chemistry, Manufacturing & Controls (CMC) expertiseBlueReg ensures CMC regulatory compliance for your projects to meet regulatory agencies requirements and expectations.

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

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Scientific Advice & Interaction with Health authorities

BlueReg has extensive experience in scientific advice with the European Medicines Agency (EMA) and many national competent authorities. BlueReg can assist with all competent authority meetings.

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EMA/HTA Parallel scientific advice

Looking for support with your EMA / HTA bodies Parallel Consultation?  BlueReg can provide a team of highly experienced consultants specialised in regulatory affairs, market access and scientific writing.  Our consultants can advise you on all steps of the procedure and author the required documents required for this important process.

Associated services

Clinical Trial Applications (CTA)

Looking to outsource Clinical Trial Applications? BlueReg offers a variety of services that bring together our global clinical and regulatory expertise to simplify your journey to market. The clinical development process can be complex and can cost your organisation significant time and money.

Associated services

Orphan Drug Designations (ODDs)

Looking to apply for ODD designations ? BlueReg can determine if your product is eligible for orphan drug designation and provide the necessary support for your EMA/FDA application.

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Paediatric Investigation Plans (PIPs)

BlueReg can provide a complete PIP writing service as well as any PIP modifications through the lifecycle of the product within the EU or US.

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CTD Dossier Writing

BlueReg can collaborate with your experts to author, review and update your Common Technical Document (CTD) as required for new Marketing Authorisation Application (MAA) submissions or during the lifecycle of the medicinal product.

Associated services

CMC Regulatory support

Our CMC Regulatory support services include everything from regulatory strategy and preparation of meetings with health authorities, assessment and preparation of regulatory documents, responses to agency questions, maintenance of products on market, regulatory compliance strategy worldwide and geographical roll out.

Associated services

Safety reports

Bluereg has extensive experience in writing safety documents and can support you with assessing a product’s risk benefit profile for your product. 

Associated services

Preparation, writing and redaction of clinical study reports

BlueReg can support you with a highly experienced team of professsionals in preparing and writing of your clinical study reports, supporting the redaction proposal and document package for submission to the EMA to comply with EMA policy 0070.


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