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I have been asked to make summary recommendations for the companies which are desirous of pursuing international business.
I would like to make five recommendations.
- Infrastructure Development. International business requires a dedicated team comprising of following functions.
- Business Development
- Regulatory Affairs
- Operations & Logistics
It is not required to have a big team; it should be a coordinated and effective team. There is sometimes a thinking to allocate part-time resources. While it may save money, but it is likely not to earn business any time soon. International business is like any other strategic business and it makes logic to invest on it.
- Leadership and Ownership. It is highly desirable that the top management takes up the leadership of international business. It helps in quicker decision making, allocation of resources, speedy actions and key initiatives.
- Selection of Export Countries. There are several countries which could be explored for business. However, if a priority of countries is established, it gives focus, saves wastage of resources and effort, and improves results.
- Inspection Readiness. Many countries are now doing mandatory inspection of plants applying for registration of products. The inspection capability of regulators in the developing countries has been supported and developed by WHO. A large number of young inspectors are highly trained in doing international standard inspection. It is also customary all over the world that the home-based industry gets preferential and relaxed treatment and the exporting countries are scrutinized stringently. Same thing happens in Pakistan. Some manufacturing units licensed by local regulators are not worthy of international inspections.
- Giving Enough Time. International business takes longer to develop. CTD dossiers are required for submission which take longer to prepare. The regulatory bodies review dossiers thoroughly and raise objections and queries. Registration of products takes time. There is wait for inspection, if included. And there may be additional conditions. All said and done, International Business has a much longer turnaround as compared to domestic business. Waiting with patience and giving enough time is critical.
I encourage Pharmaceutical companies to enter into International Business arena, dig in and get their share. Effort is never wasted and is always rewarded.
