Specific Services for the
United States

Our market specific services for the United States

The Food and Drug Administration (FDA) is responsible for protecting and promoting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices.

 

Our consultants can help navigate FDA regulations and provide support and advice for all your project requirements. Specific services provided by our team include:

 

  • Pre-Market Notification (510(k))
  • Pre-Market Approval (PMA)
  • Investigational New Drug application (IND)
  • New Drug Application (NDAs)
  • Biologics License Application (BLAs)
  • Paediatric Study Plans / Orphan Drug Designation
  • Submission to the FDA (Electronic Submission Gateway)

Our experts

Associated services

Worldwide

BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements

Associated services

Product Registration in the US & EU

Do you want to register your healthcare product in the United States or the European Union? BlueReg has a team whose expertise covers the entire development process, from concept to marketing authorization, on centralized and / or multinational projects. Our consultants have varied experience ranging from regulatory strategy to operational execution.

Associated services

International Registration

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, supported by the expertise of our consultants and our international qualified partners.

 

Associated services

United States

Looking for help with regulatory activities in the United States?  BlueReg can help to navigate the Food and Drug Administration (FDA) regulations and provide support and advice for all your project requirements.

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

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

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

Pharmacovigilance

BlueReg will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.

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

Pharmacovigilance

BlueReg can support with routine pharmacovigilance activities for early access programs, clinical trials or post-marketing

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

Scientific and CTD Dossier Writing

BlueReg provide flexible solutions for scientific writing covering all kinds of engagements or operational platforms to meet your company’s needs from product development, registration through to launch and product maintenance activities.  Our team are experienced in writing clinical modules for submission in the EU and the US, PIPs, ODDs, INDs, IMPDs and IBs, as well as briefing packages for scientific advice.  The team also manage Chemistry Manufacturing and Controls (CMC) writing for chemical and biological products.

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

Regulatory Affairs Consulting EU

Our team composed of global experts from the pharmaceutical industry provides the necessary support to help you succeed in all regulatory aspects of life sciences in Europe from development, registration through to commercialization.

Associated services

Specific Services for the United States

BlueReg consultants can help navigate FDA regulations and provide support and advice for all your project requirements

Associated News

FDA GUIDANCE – COVID-19

BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...

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BlueReg continues to expand in the US opening its second North American office in Boston

Cambridge, Massachusetts, USA, December 13 2019, BlueReg, the consulting organization for life sciences companies, is...

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RAPS Regulatory Convergence in Philadelphia

BlueReg team will attend the RAPS Regulatory Convergence in Philadelphia, from September 21st to 24th....

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