MakroCare Labeling department offers a wide range of services to Pharma, Bio-Pharma & Medical Device companies. We provide manufacturers with integrated Structured Product Labeling – Physicians Labeling Rule (SPL-PLR) services: conversion services plus authoring and/or review of the text. MakroCare can also assist manufactures on content management and submission of related documents, e.g. drafts, supplements, annual reports, CBEs, published versions, etc.

Our Labeling Services include, but not limited to:

• NDC request
• Electronic Drug Listing (eDL)
• Establishment Registration (ER)
• Information about Drug Product (API, Inactive Ingredient)
• Labeler Code Requests (LCR) through the use of SPL R4
• PIL Preparation
• Art work preparation (Label, Foil, Carton, Promotional material)
• DDMAC Services
• Designing of REMS