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In an ever changing regulatory environment, AMB Compliance provides regulatory Intelligence, expertise and solutions to support companies in the successful life cycle management of product portfolios. This includes the support needed to meet post approval commitments, post-marketing management, and the maintenance of product authorisations. Help comes in many forms, including advice, strategic planning, dossier preparation, management of submissions and compliance issues in general. Operating primarily w...

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In an ever changing regulatory environment, AMB Compliance provides regulatory Intelligence, expertise and solutions to support companies in the successful life cycle management of product portfolios. This includes the support needed to meet post approval commitments, post-marketing management, and the maintenance of product authorisations. Help comes in many forms, including advice, strategic planning, dossier preparation, management of submissions and compliance issues in general. Operating primarily w...

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Home - AMB Compliance | ambcompliance.com Reviews

https://ambcompliance.com

In an ever changing regulatory environment, AMB Compliance provides regulatory Intelligence, expertise and solutions to support companies in the successful life cycle management of product portfolios. This includes the support needed to meet post approval commitments, post-marketing management, and the maintenance of product authorisations. Help comes in many forms, including advice, strategic planning, dossier preparation, management of submissions and compliance issues in general. Operating primarily w...

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Dossiers - AMB Compliance

http://ambcompliance.com/services/regulatory/dossiers

Electronic Common Technical Document (eCTD). In December 2008 the EMEA published a press release in which they state:. From 1 January 2010, the EMEA will mandate the use of eCTD format for all electronic-only submissions for all applications (new and existing) and all submission types. Rapporteurs and CHMP members will not receive paper copies or other electronic formats.". The advantages of eCTD are:. Electronic submissions (CD/DVD or Secure Electronic Gateway) reducing the need for paper documentation.

2

Readability Testing - AMB Compliance

http://ambcompliance.com/services/regulatory/readability

Directive 2001/83/EC (as amended by Directive 2004/27/EC) requires that consultation with target patient groups (‘user consultation’) be carried out to demonstrate the readability and usefulness of the package leaflet to patients. Readability Testing (or User Testing) of the leaflet is an accepted way to satisfy these requirements. We can help you meet this requirement to perform full testing and alsocapitalise on the option to bridge / focus test when possible. Independent review of the leaflet.

3

Licence Acquisition - AMB Compliance

http://ambcompliance.com/services/licence-acquisition

The benefits of regulatory intelligence include better compliance, faster times to market and decreased costs of product development. Regulatory intelligence (RI) is a rapidly developing subtopic within regulatory affairs which is widely recognised as adding value in terms of identifying novel regulatory approaches on the path to marketing authorisation. RI thus creates. Our RI service is designed to help busy regulatory affairs departments with the key aspects:. Decentralised Procedure (DCP): When the a...

4

Pharmacovigilance - AMB Compliance

http://ambcompliance.com/services/pharmacovigilance

According to European Directive 2001/83/EC and its subsequent recent amendments, the holders of marketing authorisations are required to have a functional pharmacovigilance system in place. AMB Compliance can help to ensure that pharmacovigilance (PV) systems are properly established and ensure that Marketing Authorisation Holders meet their obligations to monitor the safety of marketed products in this rapidly-changing arena. You have two main options:.

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Renewals - AMB Compliance

http://ambcompliance.com/services/regulatory/renewals

EU Marketing Authorisations have an initial life of five years. After five years, the MA may be renewed on the basis of a re-evaluation of the risk-benefit balance. Once renewed, it is valid for an unlimited period, unless the regulators decide that one additional five-year renewal is required, based on justified grounds relating to pharmacovigilance. Advise on the optimum renewal date (where there are multiple country product licences). Prepare and submit the renewal application. Generate a Product PSUR.

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Home - AMB Compliance

In an ever changing regulatory environment, AMB Compliance provides regulatory Intelligence, expertise and solutions to support companies in the successful life cycle management of product portfolios. This includes the support needed to meet post approval commitments, post-marketing management, and the maintenance of product authorisations. Help comes in many forms, including advice, strategic planning, dossier preparation, management of submissions and compliance issues in general. Operating primarily w...

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