Colecalciferol (Vitamin D3) Authorisation in UK & EU


Over the past two years a significant number of applications of different kind- National and DCP of various preparations of Vitamin D3 whether as national or via DCP procedure have been made. The reason for this sudden interest in Vitamin D3 supplement indicated to the requirement to treat Vitamin D deficiency seen in UK, EU and the Middle East.

The founder of this consultancy firm holds a very deep experience with the technical details concerning the quality and standard of this important Vitamin

Unlike other pharmaceutical material, the relevant compendia monographs are not fully in compliance with the current regulatory requirements governing the quality of the different variants of vitamin D3 or medicinal products. Deep knowledge into these requirements gained over the years working at MHRA has been confidently acquired unattainable to other consultants. Review and assessment unique to this firm and at an expert level of the followings are offered:

  • The standard and quality of the different forms of Vitamin D3 as drug substance which varies from pure crystalline form to different concentrate forms.
  • The standard and quality of the different dosage forms of Vitamin D3 and applicability of guidelines to control their quality including related substances in relation to the vehicle used.
  • Method of analysis design and validation to ensure suitability over the shelf-life of the concentrate form and medicinal product.
  • Stability study design to ensure compliance with the current requirements and guidance reflecting the good quality of the finished product over shelf-life