A-consult

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A-Consult Group
Type Private
Founded 1983
Key people Gitte Alstrøm - CEO

Overview

A-consult group is a regulatory consulting company operating within all healthcare sectors. They ensure that their clients fulfill their market requirements all across Europe – safely and efficiently. Their services are based on expertise, close client relationships and more than 30 years of industry experience.

They know local regulations better than most. But more importantly, they know how to impact specific product and what needs to be done to certify compliance. With their expertise, they have the pleasure of serving a wide variety of clients from multinational medicinal companies and their European subsidiaries to independent marketers with limited product portfolios.

The very core of A-consult group is the team of experts and partners. These highly skilled professionals are a driving force behind the company's continued growth. Our people stay ahead of the curve on the latest regulatory changes, and through close cooperation with European authorities they also contribute to further development of the best possible regulatory environments for pharmaceutical companies.

History

Since 1983, A-consult group has been the secure and efficient way to register everything from medicinal products to dietary supplements. They deal with the complex matters of market regulations. Companies In A-Consult Group A-consult group consists of 4 individual companies. The Danish A-consult a/s was founded in Denmark in 1983. In 2005 A-pharmaconsult SAS joined the group. Additionally, A-consult Data and A-consult Holding are also part of the A-consult group.

Since the A-consult group was founded in 1983, the consulting company has remained deeply focused on helping businesses operate in a regulatory environment that becomes increasingly complex. The company's most important job has always been to deliver safe and efficient solutions to the companies they work with.

A-consult group is all about evolving with the needs of their clients. When clients internationalize, they embark on the journey with them and internationalize our own organisation.

1983 - Company is founded by Bjarne Alstrøm under the name A-CDP (Alstrøm Consult Data Pharma). Primary business areas are regulatory services within dietary supplements and programming solutions to data companies.

1985 - The company’s very first employee is hired. Many more join in the following years.

1988 - A-CDP changes its name to A-consult ApS and its legal status to a private limited company.

1992 - New restrictions regarding the registration of dietary supplements and herbal medicinal products are introduced in Denmark. A-consult expands the organisation with consultants with pharmaceutical experience.

1993 - A-consult now offers Regulatory Affairs services within pharmaceuticals.

1998 - The A-consult team reaches 14 skilled employees and moves to a new headquarter. Many new pharmaceutical consultants, programmers and IT-specialists join the company in the following years due to increasing client demands.

2003 - A new company, A-consult Data ApS, is formed to manage all data services.

2004 - A-consult expands its international operations and buys the French company Yarra SAS, located in Grasse, southern France.

2005 - A-pharmaconsult SAS is formed under A-consult Holding. The company inherits all Yarra activities and employees and so becomes an integrated part of the A-consult family.

2007 - Loic Girot is appointed General Manager of A-pharmaconsult sas.

2011 - Founder and CEO Bjarne Alstrøm retains his role as chairman of the board, but steps down as CEO and a new management team is formed.

2013 - Gitte Alstrøm is appointed CEO of A-consult a/s.

2015 - A-consult group is a reality where A-consult a/s and A-pharmaconsult sas launches a closer cooperation and rebrands their entire identity.

REGULATORY AFFAIRS - DRUGS

A-consult group provides a full range of consulting services. They can provide:

Regulatory writing (pharmaceuticals, herbal medicines, homeopathic, consumer healthcare, etc…)

  • Product positioning and regulatory strategy
  • All Modules of the MA Dossier (CTD, EU-Nees, eCTD)
  • Literature search and documentation review
  • NonClinical Overviews, Summaries & Expert Statement (Modules 2.4, 2.6 & 4 - NCES)
  • Clinical Overviews, Summaries & Expert Statement (Modules 2.5, 2.7 & 5 - CES)
  • Technical writing and Quality Overviews
  • Writing of ASMF, DMF and CEP
  • Switch core dossier, Export
  • Drug product information: SPC, PIL
  • PSUR writing and submission, evalution of AEs
  • Submission to the Health Authorities (National, MRP, DCP, International, etc)
  • Compilation of documentation for Marketing Authorisation
  • Preparation of Marketing Applications (New, Variations, Renewals, etc)

Regulatory maintenance

  • Compliance reviews and Deficiency reports
  • Conversion/update into CTD/eCTD/EU-Nees formates
  • Management of variations, line extensions and renewals
  • Advertising/labelling compliance
  • Proofreading and translations
  • Reimbursement/Price dossiers
  • User testing
  • Due diligence

References

http://www.a-consult.dk/

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