The regulatory affairs requirement in any regulated lifesciences industry is very
important to the public's well-being. Regulatory affairs have specific requirement to fill and that is
of labelling. The regulatory affairs labelling team works to control the safety and efficacy of a
range of products, including pharmaceuticals, medical devices, cosmetics, food, consumer healthcare,
fmcg, etc. and the companies who research, manufacture, and market these products.
Regulatory affairs labelling is responsible for creating, updating, and maintaining labelling
records throughout the life of a product. They will ensure that products meet regulatory labelling
Labelling is required for identifying a product, to provide information such as ingredients, purpose,
manufacturing date, expiry, batch number, etc. It also states any caution for misuse. Label come
attached to a product and it has decoration or design to the content. This information is available in
varied components. Label contains information for use meant for the consumer of that product. This
information is legal requirement and manufacturers must abide by those requirements in order to
commercialize their products in the market.
Knowledge and proficiency required for regulatory labelling depends on the industry it is meant for.
Labelling regulations and global product labelling regulations are different with respect to regions
and industry. Labelling team in Athreva creates product labels and maintains databases of labels,
ingredients, and formulas; therefore, strong attention to detail and efficiency in proofreading, data
entry, and database management is core to our service delivery. Adherence of good manufacturing
practice (GMP), quality and safety practices are also part of our regulatory labelling team. Labelling
team not only interacts with regulatory affairs team but also cross-functionally with other
Labelling expert is responsible for reviewing, correcting and approving labels on food
products. It includes developing labels which has various parameters concerning food products, like
the name of the product, weight information, ingredients' concentration or percentages, allergens and
nutrition facts and complies with company standards. Labelling expert has to ensure that all the
details on labels are accurate and are in accordance with government regulations and the packaging
design has all the required elements.
As sub-section of regulatory affairs team, Labelling experts are required to make sure
the packaging components, i.e.; carton, label, leaflets, tubes, etc. are complying with the regulation
of the health authority of the concerned country. Packaging artworks that will be used for commercial
purpose is approved by the concerned health authority via submission and the content that is available
is as per the current requirement.
Labelling stakeholder in pharmaceutical companies works closely with the artwork studio and creates
artworks for submission and commercial purposes for a drug. Proofreading of artworks created by studio
against the regulatory requirements is the primary job and also ensures artwork content meets medical
and legal requirement of the country where the product as to be marketed. The accuracy and regulations
in content has to be checked at the time of submission and again at the time of commercialization of
A labelling expert has to provide and create content for the labelling documents required as part of
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