Regulatory Affairs Unit in a pharmaceutical company is a vital unit that drives the R & D efforts of the company to the market successfully. Today a Regulatory Affairs department is a dynamic business unit which works with a focus to get products to the market with a commercially viable label in the least possible time and expenses.
Today the world has become a global village and many companies are in a race to place many new products in the world markets to gain market share and increase earnings. In such a scenario a small delay in gaining market access means huge loss in terms of market share and revenue generated.
The key to success for pharmaceutical companies lies in obtaining timely marketing approval from regulators. So to obtain timely marketing approval companies can either strengthen then regulatory department or outsource the same to regulatory affairs consulting firm.
With changing global regulatory norms, outsourcing regulatory affairs work seems a more beneficial option both in terms of time and money. Maintaining a large regulatory affairs department can be very expensive and scope of knowledge can be limited to certain aspects. On the other hand a regulatory affairs consultant keeps on updating himself with the current regulation and has vital experience in the field to expedite the approval process.
Regulatory affairs outsourcing is on a growth worldwide, many large and small companies have adopted this strategy to get a timely approval. Even multinational firms are outsourcing their regulatory work to lessen the pressure on their in house team or to support the same.