Product Information / Technical File Compilation (PIF)

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Overview

Claims and Labelling are the important aspect of the marketing of the cosmetic product. Correct acceptable claims are required to successfully launch the product in the market, using unacceptable claims results in different classification or may lead to follow more stringent regulatory requirements. Unacceptable claims may classify the product as Drug or Biocides or OTC products.

Incorrect claims or unacceptable claims may also lead to product recall. Cosmetic claims review for any therapeutic claims with respect to ingredients used and suggest the alternative acceptable claims based on scientific reason or as per our experts experience.

Expertise

  • At Maven we are expert in claims assessment and let you know which type of wordings or activity is acceptable for cosmetics and can be used on the label for better marketing without changing the intended use of the product. Also with our expert team we can also substantiate the claims based on scientific literature or ingredients based claims.
  • Label Review as per country specific regulations and ensuring the all mandatory labelling information to be placed on the label.
  • Labelling regulations are different in each country, making a global complaint harmonized label is also a big challenge.
  • We at Maven review the label as per local regulations and harmonize the label based on the similar content that is required and on discussion and slight adjustment make a global complaint label.
  • We at Maven follow all health authority regulations for harmonizing the labelling.
  • Label review as per Europe regulation 1223/2009, FDA’s Food Drug and Cosmetic Act and Fair Packaging and Labelling act, Canada’s Food and Drugs Act, Cosmetic Regulation, the Consumer Packaging Label Act etc.
  • Product Information / Technical File Compilation
  • Product information file or technical file is type of cosmetic dossier and need to be in place before the product is placed in the market.
  • Though it’s not needed to submit complete PIF to health authority for approval, but all the documents need to be in place as health authority may request any time for information.
  • At Maven, we understand the PIF requirements and gather all the technical documents required for preparation PIF and summary of PIF will be in place to understand all the documents in place.
  • As a part of PIF, product related documents, raw material documents and safety documents are reviewed and suggest for missing mandatory documents.
  • At Maven, we can also suggest for administrative documents required as per local regulations.
  • Maven is expert in PIF Compilation, Gap analysis on the existing data a and updating with the required information and also do the regular update to PIF with changes related to raw material or manufacturing.

Advantages

  • Cost-effective
  • End-to-end Regulatory consultation
  • Qualified team of experts with hands-on experience across all categories of personal care and cosmetic products like Skincare, Oralcare, Hair care, Baby care and beauty products.
  • Expert support for region-specific Regulatory complexities
  • Interactions with Health Authorities (HAs)
  • Structured approach to ensure quick product launch or market access