Blue-reg.com

Product Registration in the US & EU

WebProduct Registration in the United States & Europe. Clients request the help of BlueReg to provide the expertise in registration strategy in the US or in Europe, to provide the …

Actived: 5 days ago

URL: https://blue-reg.com/service/registration-in-us-and-eu/

Specific Services for the United States

WebSpecific 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 …

Category: Food Go Health

Paediatric Investigation Plans (PIPs)

WebA Pediatric Investigation Plan (PIP) or Pediatric Study Plan (PSP) is a development plan intended to support the authorization of a medicine for children by ensuring data are …

Category: Medicine Go Health

BlueReg Group Pharmaceutical consulting for life sciences industry

WebBlueReg is a pharmaceutical consulting company which operates since more than 10 years in the pharmaceutical industry partnering with life sciences companies in their ability to …

Category: Health Go Health

Comply with french regulations and take advantage of early access

WebFrance Market Specific Regulations. In addition to the European regulation, the French Market is closely monitored by the ANSM (Agence nationale de sécurité du médicament …

Category: Health Go Health

Market Access France

WebBlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical …

Category: Medical Go Health

How to accelerate your pharmaceutical product launch in Europe

Web4. The notification of your launch at national level. 5. The registration of your products in local databases. 6. The preparation of your congresses and communication …

Category: Health Go Health

Registration of Medicines in the Eurasian Economic Union (EAEU)

WebAfter the Decision No. 78 of the Board Eurasian Economic Commission (EEC) on November 3rd, 2016, the “Rules” for registration and expert review of drugs for …

Category: Health Go Health

Scientific Advice & Interaction with Health authorities

WebScientific Advice and Interaction with Health Regulatory Agencies. BlueReg has extensive experience in scientific advice with the European Medicines Agency and many national …

Category: Medicine Go Health

Drug Registration and Regulatory Roadmap

WebThe regulatory roadmap outlines major development milestones and success criteria, facilitates cost and timeline estimates, and provides a basis for sound decisions and …

Category: Health Go Health

Promotional Material Compliance

WebNovember 23, 2021. Two pharmaceutical companies sought solutions for review of promotional and non-promotional materials to ensure compliance with the European …

Category: Health Go Health

Clinical Trial Applications (CTA)

WebClinical trials are investigations conducted in human subjects intended to discover or verify whether new drugs, diagnostics or treatments are effective and safe for people to use. …

Category: Health Go Health

Définition PSUSA

WebPeriodic Safety Update Report Single Assessment. The PSUSA is a safety report required by the European Medicines Agency (EMA) for all human medicines from marketing …

Category: Medicine Go Health

Pediatric Investigation Plan BlueReg

WebA Pediatric Investigation Plan (PIP) is a formal document requiring coordination and consistent planning of studies on children population throughout Europe for medications …

Category: Health Go Health

Export Countries

WebOutsourcing Platform on Registration for Export Countries “OPREC”. BlueReg is your strategic partner to meet your goals for all medicinal product registrations worldwide. …

Category: Health Go Health

Registration Strategy

WebBlueReg is registered as SME (Small and Medium-sized Enterprises) by the EMA and can assist and act on behalf of companies outside of EU for applications in Europe. EMA …

Category: Health Go Health

SME representation

WebBlueReg is registered as SME (Small and Medium-sized Enterprises) by the EMA and can support non European economic area ( EEA) enterprise by accessing micro, small and …

Category: Health Go Health

Promotional Material Review in France

WebPromotional Material Review. The BlueReg team of experienced consultants can provide full support to meet your business objectives, whilst ensuring full compliance to the …

Category: Health Go Health

Pharmacovigilance

WebQualified Person Responsible for Pharmacovigilance (QPPV) BlueReg can provide you with a EU-QPPV (European Qualified Person Responsible for Pharmacovigilance), French …

Category: Health Go Health

RESPONSIBLE PERSONS FOR PROMOTION OF MEDICINAL …

Web2 The promotion of medicinal products is governed by different regulations and codes in the European Union (EU). In particular, the Directive 2001/83/EC ‘of the European …

Category: Health Go Health