MRA Regulatory Consultants was established in 2003 to provide expert regulatory advisory services and regulatory support services to the pharmaceutical industry.
MRA Regulatory Consultants has a clear understanding of the regulatory environment in South Africa, its history, trends, current requirements and policies. They are associate members of many of the industry associations and in their professional capacities affiliated to the professional associations. These associations, together with networks they have nurtured, provide them with current information related to the health products industry.
Their aim is to provide exemplary quality regulatory support, thereby reducing unnecessary delays in the registration process.
They use the most up to date software solutions to enable us to compile and publish eCTDs and paper CTDs. They are able to life-cycle manage documentation, thus maintaining registration documents in a fully validated electronic document management system.
They aim to empower their customers with the knowledge and understanding of the regulatory environment and processes. This is vital to their clients to understand the regulatory environment related to the industry and enables them to make informed decisions regarding their products.
Contact
Physical Address:
381 Rossouw Street
Murrayfield
0184
Pretoria
Postal Address:
P.O Box 71351
The Willows
0041
Pretoria
Email: info@mra-regulatory.com
Tel: +27 (0)12 803-1039 / -6223 /-5955
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Gavi, the world’s largest vaccine-focused public-private partnership has a new leader. Pakistani Senator Dr Sania Nishtar has officially assumed the role of CEO following a period of leadership uncertainty for…
The latest pharma news from Singapore, including J&J Innovation’s continued investment in Singapore; Evotec’s new Singaporean venture, 65LAB; BeiGene’s cancer drug approval in the country; Novo Nordisk’s acquisition of local…
A doyen of Portuguese pharma, Pedro Ferraz da Costa is the long-serving president of the company started by his parents, Iberfar. In conversation with PharmaBoardroom, he discusses how Iberfar’s business…
Sovereign wealth funds (SWFs) in the Gulf Cooperation Council (GCC) countries are increasingly investing in healthcare and the life sciences to reinforce their local industries and pursue the region’s economic…
A roundup of the latest news from Spanish pharma, including Almirall’s licensing deal with EpimAb Biotherapeutics; the opening of Insud Pharma’s oligonucleotides centre in India, and Esteve Química’s new FDA-cleared…
Dr João Filipe Raposo outlines the importance of a collaborative, multidisciplinary approach to diabetes care management, an approach embodied by the APDP – Diabetes Portugal. He also touches on the…
The APAC region —with an approximate ten percent growth in trial numbers between 2017 and 2022— is rapidly becoming the world’s leading market for clinical trials. Karen Chu, CEO of…
Pedro Moura, managing director at Merck Portugal, outlines the company’s unique presence and the Portuguese affiliate’s diverse portolio. He discusses the challenges around access to innovation in Portugal, where only…
Sanjay Bhutani of Bausch & Lomb outlines why the medical devices sector in India is poised for substantial growth, bolstered by increased government support and a higher healthcare budget. He…
A roundup of some of the latest news from Chinese pharma including CanSino’s Gates Foundation grant for polio vaccine R&D; Merck’s deal with Jiangsu Hengrui; the license agreement between GSK…
The State of Gujarat is one of India’s most culturally diverse, the birthplace of ‘Father of the Nation’ Mahatma Gandhi, and the only place in the world where Asiatic lions…
President of the Portuguese Association Against Leukaemia (APCL), Dr Manuel Abecasis is known as the father of bone marrow transplants in Portugal. He outlines the APCL’s activities, including the organisation’s…
Maher Abouzeid outlines Medserve’s role as a healthcare projects incubator, focusing on identifying and filling gaps in healthcare services across the Middle East & Africa region. Their hands-on approach includes…
Despite its ageing population and growing need for healthcare, South Korea had just 2.6 doctors per 1,000 inhabitants in 2022, one of the lowest numbers among developed nations. To deal…
France is the third most significant clinical research destination in Europe, participating in 50 percent of the trials initiated across the continent. While favourable government policies and unique strengths such…
Paula Barriga, VP & GM at Novo Nordisk Portugal, discusses the high prevalence of obesity, which affects over two million people in a country where none of the available pharmacological…
PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient…
Portugal’s strong legal framework along with its low production costs and strategic location within Europe have given rise to a thriving medicinal cannabis sector. With exports in 2022 that surpassed…
Mexican voters will be heading to the polls next June for what will be the largest election process in the country’s history with concurrent state and federal elections. The election will…
An overview of some of the biggest stories from Latin American pharma and healthcare, including Brazil’s rollout of dengue vaccines following a sharp increase in cases; the Brazilian regulatory agency…
Thanks to what AstraZeneca country president Rick Suarez called a “thriving life-science eco-system and highly-skilled talent pool,” along with Spain’s leading position in clinical trials, the British Big Pharma is…
UCB has been undergoing a far-reaching digital business transformation, integrating novel approaches across its R&D organisation, including Computer-Aided Drug Design (CADD) and AI, while striving to maintain a patient-centric focus.…
Managing director & CEO of Ferring India, Sudheendra Kulkarni, whose responsibilities have grown to cover the entire 10-country South Asia & ASEAN cluster, speaks about Ferring’s Indian footprint, which includes…
India’s chemical industry is of vital importance to several industries, including pharmaceuticals, and exported USD 30.18 billion worth of products in 2022-23. Chemexcil’s Raghuveer Kini discusses his industry’s key role…
Dr Basant Garg explains the role and impact of the National Health Authority (NHA) in India, including its pivotal role in executing the Ayushman Bharat universal health coverage initiative. Dr…
The Bombay Chamber of Commerce, established in 1836, played a key role in India’s industrial and infrastructural development during British rule and has since evolved into a professional organization with…
Nominated by President Joe Biden, the National Institutes of Health’s (NIH) new director Monica M. Bertagnolli took the reins of the world’s largest public funder of biomedical research earlier this…
PharmaBoardroom caught up with Niklas Hedberg at DIA Europe 2024 in Brussels to gauge what more needs to be done ahead of the implementation of European HTA regulation in January…
Shailesh Siroya explains the rationale behind Bal Pharma’s strategic focus on niche products within the API segment, avoiding the broader, more competitive commodity markets and enabling it to establish a…
SaudiVax, a pioneering force in the halal vaccines field, has recently expanded its focus to include biologics, aligning with broader market trends towards vegan and Halal products. Co-Founder and Managing…
Morocco is undergoing ambitious reforms, extending universal healthcare coverage to all its citizens while resolving the shortcomings laid bare during the COVID-19 pandemic. Endorsed by a USD 450 million Program-for-Results…
Haematological oncologist Dr Raymond Liang, gives his take on the adoption and challenges of CAR-T therapy in Hong Kong, the necessity of collaboration with mainland China for patient referrals and…
Tremendous strides have been made in both treatment and prevention of AIDS and it is no longer among the 10 leading causes of death globally, however an estimated 39 million…
A roundup of some of the biggest news stories from the pharma industry in China including Aspen’s purchase of Sandoz’s Chinese business; Moderna’s first mRNA facility in China; WuXi Biologics’…
The US Food and Drug Administration has increasingly recognized the importance of diversity and representation in clinical trials over the past few decades. This evolution reflects growing awareness across medicine…
Under the leadership of Ajay Tandon and the foundational work of Dr Kiran Marthak, Indian firm Veeda Clinical Research has strategically expanded its capabilities and global footprint. The company has…
The Indian pharma industry has demonstrated spectacular growth based on its strength as a global generics manufacturer. Yet Indian pharma is not merely resting on its laurels. After shining through…
A roundup of some of the biggest stories from Italian pharma and healthcare, including Italfarmaco’s FDA approval for its DMD treatment; Alfasigma’s acquisition of Galapagos’s Jyseleca, the antibiotics deal between…
The recent FDA decision to investigate the serious risk of patients developing new cancers after treatment with CAR-T therapies may have created some bad press around cell and gene therapies,…
In 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China…
Every year, the world’s top business and political leaders converge on the ski village of Davos, Switzerland for the World Economic Forum meeting. Read on for some of the key…
After positions at Novartis and Merck, Bettina Bauer, a trained scientist, joined Gilead in 2019 as VP and general manager of its German affiliate. Today, as the VP of the…
Azevedos Group’s João Sotana outlines the firm’s diverse strategic pillars, including manufacturing for Portugal and international markets; its focus on sustainability and innovation; and how it plans to stay ahead…
Luis Abrantes explains how Generis, as one of the leading companies by volume in both the retail and hospital segments of the Portuguese pharma market, serves a huge number of…
Director of the oldest and largest cancer centre in India, the Tata Memorial Hospital, C S Pramesh also heads up the National Cancer Grid (NCG), a nationwide network of over…
A roundup of some of the most important recent pharma news from the dynamic ASEAN region, including a big new investment from Novartis in its antibody plant in Singapore, the…
The biggest pharma industry stories coming out of China, including the impact of the US Biosecure act on Chinese giants WuXi AppTec and WuXi Bio; Novartis’ acquisition of SanReno Therapeutics;…
Johnson & Johnson has been building its medtech arm and creating a differentiated pipeline through strategic M&A, an approach that generated USD 30.4 billion in medical device sales last year,…
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