Drug Master Documentation

Drug Master Documentation

We are located in Noida (Uttar Pradesh, India) and involved in offering services for drug master documentation. We are capable of preparing documentation for active pharmaceutical ingredient(s), excipients, and other intermediate products. We prepare the drug master file (DMF) that is known as the master document which contains complete information on active ingredient compliance for open and closed (restricted) part. DMF contains the confidential information on a drug such as its chemistry, raw materials, purity or impurity profile, manufacture, stability, purity, packaging, and cGMP status of any active ingredient or excipients.

There are four (4) types of DMFs :

  • Type I: For Active pharmaceutical ingredient(s), API
  • Type II: For Packaging materials
  • Type III: For Excipients
  • Type IV: For Products

We cover DMF’s for Type I (drug substances - API’s) and Type III (for excipients - inactive ingredients). This file is further submitted to FDA for approval.

We also cover studies like :

  • Process Validation
  • Stability data studies
  • Analytical Report (COA)
  • Analytical Method Validation
  • Structural Elucidation Studies (Elemental Analysis, IR, Mass, MR C & H, XRD, DSC),
  • Determination & Validation of Potential Impurities & Solvent Impurities

In addition, we have tie-ups with the well-known laboratories (NABL Certified) that conducts the analytical testing. The data we offer is supported by necessary Chromatograms & Spectrums.

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