Hridkamal Roy, Assistant Managing Editor, India Pharma Outlook
Pharmaceutical manufacturer Haleon appointed McKinsey & Company and EY in September, 2023 for restructuring and cost-cutting operations. Haleon was valued at 35 Bn after splitting up from GSK and is a recognized manufacturer with diverse portfolio that includes toothpaste, nasal drops and others. In order to organize operations, it became important for the organization to take services from a pharmaceutical consulting company.
It is the duty of pharmaceutical consultants to provide services all along a product lifecycle that includes processes like planning, design and construction, commissioning and testing of products.
“Systems in the pharmaceutical industry has strengthened and changed post covid. Lots of migrations are taking place in the industry and automation has also been introduced to the industry and pharma consultants are playing a major role in this transformation. Companies have been taking measures to gain sustainability post covid and this is evident all across the industry”, mentioned Duraimurugan Anbalagan, CEO, FWQRC-Global Regulatory & GxP Consultant.
Pharmaceutical consulting firms play a vital role in shaping product life cycles and help in improvement of drug development processes and also provide guidance on GMP, GCP and GLP. Let us now look into some of the primary considerations that pharmaceutical companies must think on before hiring a consultancy firm.
Before choosing a consultant, a pharmaceutical company must first assess its specific needs and ask itself a few questions. The first query is whether to hire a consulting company or an individual consultant. If a company is hired, then that firm will address the problem by providing all consultants from relevant fields in order to come to a solution. On the other hand, if an individual consultant is hired then it becomes the sole responsibility of the pharmaceutical company to find, evaluate and finally choose the right consultant for the job.
Pharmaceutical consultants currently provide a wide array of services and choosing from a wide variety of options can at times slow down the consultancy process. This is the reason why it is important why it is important to specify the exact requirement right from the onset of the project. The company needs to ensure that all the deliverables and service requisites are clearly defined so that there is no confusion in implementation and delivery.
A lot depends on the fact whether a company requires speedy disposal of projects or quality delivery. If a pharmaceutical company wants project delivery comparatively faster, then they can hire a consultant who has experience in delivery very fast. On the other hand, if quality delivery is the requirement then the company must hire a competent consultant who will be able to deliver the project at the level the company requires.
Once the requirements are set, a company can be able to assess the right kind of consultant that is suited for the project. In this regard, it should start having discussions with consulting firms in order to check the amount of expertise they possess and how much productive they can be for the project.
First, it is to be checked as to how much relevant experience does a consultant or a consulting firm has. Further, it also needs to be determined whether they have the exact experience the project requires or relevant experience which means they have worked on similar kind of project but not the exact same service that the project requires. This assessment will help a pharmaceutical company decide on the right consulting firm that will be able to deliver top quality results within the specified time.
Currently, it is utterly important for a consulting firm to have knowledge about Electronic Quality Management System (eQMS). So, a pharmaceutical company must go in-depth and gain complete information from the consultant on their relevant experience with the software and what were the results that were gained last time they worked on a similar project. If a project revolves around up-gradation or implementation of eQMS, it is very important for the consultant to be experienced in order to drive the best possible results.
Last but not the least, while choosing a pharmaceutical consulting firm, it must always be considered that the entity is located in the native country of the project or neighborhood countries. Only then will a consultant will have knowledge about the local regulatory clearances and guidelines and provide accurate services.
After choosing a consulting firm, a pharmaceutical company must get into discussions about the expertise that they can offer and if they have previously worked on products all across the life cycle. Detailed interviewing should take place and both parties must come to an understanding on each and every step of the process.
There have been emergence of many pharmaceutical consulting start-ups but most of them lack experience in handling regulatory affairs, pharmacovigilance and quality assurance. However, in the end, the right consultant should always be decided based on the specific needs of a project.
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