Regulatory Labelling


Regulatory Affairs - Labelling

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 requirements.

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 stakeholders.

Athreva is catering to varied industries and catering
to the requirements

  • Pharmaceutical Labelling
  • Consumer Healthcare
  • Cosmetics Labelling
  • Medical devices Labelling
  • Food Labelling
  • FMCG Labelling

Labelling specialists in Athreva has expertise in following functions

  • Create, modify and maintain Company Core Data Sheet (CCDS) and Structured Product Labeling (SPL).
  • Create, modify and maintain labelling content through SmPC or USPI for product labels, cartons and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices following the established design format, labelling style guidelines and branding guidelines.
  • Works on commercialized and new product introduction labels. Supports cross-functional team in collecting labelling content and translating it into functional label layouts.
  • Works with other functions to identify and resolve labelling inconsistencies with labelling material and requirements.
  • Initiate label change or collaborate with label change request initiators to plan, prepare and submit complete and accurate change requests. To make sure labelling content validation is done as required.
  • Maintains knowledge of new developments in packaging and labelling technologies.
  • Handles different regulatory body regulations of the intended country.

Example - Food Industry

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.

Example - Pharma Industry

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 product.

A labelling expert has to provide and create content for the labelling documents required as part of SPL/PLR compliance.