Regulatory Outsourcing

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We are services company that encompasses innovative, cutting edge and high quality services. The company resource consists of high end professionals with proven track records in their domain of expertise.

Regulatory Outsourcing

Today Pharmaceutical Industry is passing through a very challenging period in its evolution as the traditional approaches to drug development constantly expanding. On one side there is tremendous pressure on the Industry to reduce the cost of drugs and on the other hand, operational costs are skyrocketing. In addition to these are complex regulatory requirements, declining revenues from the lost sales or delay in regulatory approvals and pressure from government for a reduced healthcare cost. Given these difficulties, pharmaceutical companies across the world have realized the need to leverage resources, and the expertise provided by specialist external sources.

In the last ten to fifteen years Big Pharmaceutical companies have outsourced almost all processes Chemistry, Clinical, Non Clinical, Logistics, IT, Marketing, and all other non-core processes. In spite of the cost and business benefits, companies were cautious in outsourcing some functions like IP, Regulatory Affairs, etc. as they are the most vital functions that drives R & D efforts of the company to the market successfully.

However, with companies expanding into global markets and with changes in the clinical landscape, most companies have tested unknown destinations. This has turned into a positive note as it has reduced the overall cost. Companies have realized that the key to success lies in obtaining timely marketing/clinical approvals from regulators. Therefore, to obtain timely marketing/clinical approvals companies have either strengthened their regulatory department or outsourced this to regulatory affairs consulting firm.

It is becoming a daunting task for Pharmaceutical Companies to address local regulatory challenges as well as constant changes in the regulations of major markets such as Pakistan. Staying in compliance with existing regulations has become an overwhelming chore, let alone trying to stay current with developments across the globe. Amendments to existing regulations promise to further complicate the regulatory path for the industry. As a result, demand for outsourced regulatory expertise is rising. Whether the need is simply to procure more able consultants to help with submissions or surveillance efforts, or the need is for deeper regulatory knowledge in specialty areas, such as (Clinical Regulations, Dossier Requirements, Quality System Requirements, Labeling, etc).

RA Consultants (RAC) is one of the most significant Management companies in Pakistan, involved in providing business services to both national and multinational companies. RAC consists of the most elite and top-notch experts from the industry with decades of experience in their respective domains. We have proven our self in every field by providing the best services and a 100% success rate.

We are constantly improving and evolving and as we step into a new year of business and because of the high demand of services, we are introducing Regulatory Outsourcing to better cater your company’s needs and to improve our quality further. As stated above outsourcing is a cost-effective way of doing business, as it will cut down the cost of running a whole regulatory department.

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