Due Diligence in Pharmaceutical Industry Online

Research and evaluation of pharmaceutical products and production processes is a multi-stage process that requires the involvement of competent specialists in relevant fields. Here is more about pharmaceutical due diligence.

The trends of the world pharmaceutical market

The development of the pharmaceutical industry in the direction of development and implementation of the most effective and safe drugs is a priority for many leading countries and the most famous pharmacological companies. This is due primarily to the social significance of the industry’s products, and changes in the demographic situation in all countries.

Most of the medicines (over 75%) that enter the world market are produced in the USA, Japan, Germany, France, Great Britain, Switzerland, Italy, and Spain. These countries are producers of original, most effective, and high-quality medicines. The dynamics of the global pharmaceutical market over the past 10 years show that drug production is today and will remain in the future one of the most promising industries.

Currently, the most knowledge-intensive and profitable field of the pharmaceutical industry, which has the advantages of a developed segment of R&D, is biotechnology. In world practice, more than 50% of investments aimed at financing developments in the biotechnology field are accumulated by developed companies.

Among the leading pharma companies in the world there are:

  1. Roche
  2. Novartis
  3. Sanofi
  4. Takeda
  5. Jonson&Jonson
  6. Pfizer
  7. Merck&Co
  8. AbbVie
  9. Takeda
  10. GlaxoSmithKline

The role of due diligence in the pharmaceutical industry

One of the factors that allow the global pharmaceutical industry to maintain growth is the trend associated with the processes of consolidation, mergers and acquisitions (M&A). This process is carried out by companies to expand their business and enter new markets, as well as to find new technologies for drug development and research. An important driving force of M&A agreements is the desire of pharmaceutical and biotechnology companies to take a leading position in the pharmaceutical market. In this case, the due diligence procedure plays an indispensable role.

Due Diligence in the pharmaceutical industry is a thorough examination of a pharmaceutical product or technological aspects of a manufacturing process, including product technology, manufacturing process or manufacturing technology, and information and communication technology.

The main tasks of due diligence include:

  • verification of provided financial, legal, and other information;
  • assessment of the company’s competitive advantages;
  • checking the correctness of documentation and timeliness of tax and statistical reports;
  • management check on the level of competence;
  • evaluation of the business plan for the possibility of its implementation.

This procedure is a comprehensive diagnosis of the business as an object of sale, which consists of collecting, processing, summarizing, and analyzing information about the company’s activities in all areas of activity to ensure the accuracy of data provided for analysis, their compliance with laws and the absence of inaccuracies and distortions.

Manufacturing process assessment: what is the procedure?

The assessment of the production process depends on its complexity. It should include issues of technology, duration of the process, availability of production mechanisms, production time, and production conditions (e.g. sterility, high power, etc.)

To assess the production process, you need to answer the following questions:

  • Has the most optimal technology been chosen for the product being manufactured?
  • How practical and efficient the manufacturing process is?
  • Is it based on scientific principles?
  • Can the manufacturing process be safely scaled up to a large production scale?
  • Does production at the current scale make commercial sense (process time)?
  • What are the strengths, weaknesses, and risks of the manufacturing process?
  • What are the problems with a possible relocation of the process?