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A-pharmaconsult is a pharmaceutical consultancy that specializes in Regulatory Affairs for Medicines and Medical Devices, including medical writing, non-clinical writing, technical writing, regulatory strategy, and quality systems.
Its offerings include preparation of marketing authorization dossiers for drugs, technical documentation for medical devices, regulatory consultancy and documentation for quality management systems (GMP, GDP, ISO 13485 & ISO22716).
Vision and Mission
From both its Danish and French origins, this consulting company has remained deeply focused on helping pharmaceutical, medical devices and cosmetics businesses operate in an increasingly complex regulatory environment, underpinned by core values of expertise, respect, and confidence. In this way, A-pharmaconsult has built long term partnerships across a broad range of different companies with a “tailor made” offering to suit every size of company and specific needs.
Over the past two decades, A-pharmaconsult has become increasingly international in reach and scope as part of its vision of ‘Together towards excellence’, in order to develop and maintain the products and solve their relevant and challenging issues.
Products & Services
A-pharmaconsult services can be grouped under four main headings:
Drug products: Serving human and veterinary medicine markets with preparation and maintenance of Marketing Authorization Application (MAA) dossiers, gap analysis, research and writing services covering drug, clinical and non-clinical modules, chemistry manufacturing controls (cmc), regulatory strategy, product information, and expert reports.
Medical Devices: product positioning and branding strategy for European and international markets, writing of technical documentation according to annexe II & III of the MDR 2017/745 and 2017/746, MD development assistance to comply with regulatory requirements, and regulatory compliance.
Quality: quality assurance (QA) and quality control (QC) advice plus development assistance to comply with quality requirements. Implementation/update of a Quality Management System (GMP, GDP, ISO 13485, ISO 22716).
Cosmetics: writing of Product Information File: safety, efficacy and manufacturing parts, including Safety reports (Part A & B), product positioning & strategies for European and export markets, product development assistance for regulatory compliance, and regulatory intelligence.
Company History and Structure
A-pharmaconsult traces its history back to 1983 and Bjarne Alstrøm’s founding of the founding of Alstrøm Consult Data Pharma (A-CDP) in Copenhagen as specialist in regulatory services within dietary supplements and programming solutions to data companies.
Within three years A-CDP had become A-consult ApS, expanding into more extensive pharma consultancy.
During the 1990s, A-consult expanded its teams to include many new pharmaceutical consultants, programmers and IT specialists and in 2003 formed a new company, A-consult Data ApS, to manage all data services.
In 2005, A-consult expanded its international operations by acquiring Yarra SAS, located in Grasse, southern France, and integrating its pharma consultancy expertise into the A-consult family as A-pharmaconsult SAS, with Loic Girot becoming its General Manager in 2007.