The aim and objective of IGRS is to deliver both scientific excellence and unmatched service to every company we serve. Our job is to work with our clients to get their pharmaceutical products to the market and keep them there.

Our team is committed to a high degree of ethical standards in our operations and maintenance of strict confidentiality essential to protect your data and intellectual property. Client’s data security and confidentiality is assured to the highest level. Speed is the essence of today’s competitive business environment, therefore we help in getting to the market faster and on time, by providing excellent and cost effective regulatory services. We can act as a bridge between the regulatory bodies and your company and help in ‘before’ and ‘after’ product launches.

IGRS can provide services to companies for identification of worldwide regulatory requirements. Very often, a client simply doesn’t have the time to complete the work. That’s where our consulting services help. We will work with you to ensure that your requirements are met and that your completed work is delivered on time and, crucially, within budget.

We are always up to date with current legislation, regulatory requirements, industry initiatives and interpretations of the regulations. Our team shall provide up-to-date guidance on regulatory requirements for products under development, as it is difficult for companies to be totally aware of all the regulatory requirements worldwide for every type of product.

We are Innovative, constantly seeking new and different solutions to deliver cost-effective, quality results. We provide tailored and comprehensive regulatory affairs solutions to meet client’s specific needs. We can ensure that your products are regulatory compliant on either a worldwide basis or at national level depending on your particular requirements.

BACKGROUND:

Regulatory Affairs Unit in a pharmaceutical company is a vital unit that drives the R & D efforts of the company to the market successfully. The 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. To achieve this, companies can either strengthen their regulatory department or outsource the same to regulatory affairs consulting firms like us.

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/herself 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.