PIL Review and Labelling Services

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PIL Review and Labelling Services

PIL Review

We offer support in preparing and maintaining Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs) for your products. This includes PIL writing, user testing, post approval changes to product information and SmPC reviewing. This service ensures that your product information comply with EU regulatory requirements. Every marketing authorization holder is legally responsible to keep the product information up to date.

We share the following responsibility with our client in this specific category:

  • For generics, to ensure that PIL and SmPCs are in line with brand product information.
  • We track any safety trigger that may be issued by the health authority, various articles, referrals, pharmacovigilance working party recommendations, PRAC recommendations.
  • We ensure that product information comply with every safety requirement issued by the regulatory bodies across EU.

Apart from these, we offer proofreading of your product information, ensuring that the labeling texts comply with the latest version of Quality review document (QRD) issue by CMDh.

We also offer services in developing and maintaining company core data sheets (CCDS) and core safety information (CSI).

Irrespective of how your product is registered across EU (i.e. MRP, DCP, CP or national), we ensure that your labeling texts comply with each and every regulatory requirement and are of highest standards.