7 best practices in regulatory outsourcing

Regulatory outsourcing is now gaining more significance in the market as more and more companies are turning to outsourcing providers to help them with the complex task of managing the compliance and regulatory needs.  Outsourcing regulatory affairs have become a common practice among the companies especially by Pharma and bio-tech companies.

However, the companies should make it a mandatory practice to measure the benefits of outsourcing against the cost incurred. They should also pay due diligence in selecting the outsourcing partner as any activity if done wrongly will impact their business and will question its existence. Below is a discussion of seven best practices in regulatory outsourcing followed by Pharma companies. These best practices in regulatory outsourcing can serve as a reference for the companies who are looking out to outsource regulatory affairs.

  1. Track record of outsourcing partner:Companies that look to outsource regulatory and compliance affairs always considers the previous track record of their outsourcing partner. They analyze whether the service provider possesses the required expertise and experience and how far they are recognized in the industry. Firms will track satisfaction of outsourcing partner’s clients in meeting SLA terms though reference calls and visits.
  2. Customer references:Companies use customer references to choose the right outsourcing partner. They try to find out past or existing customers of the potential service provider and ask them how far they are satisfied with the service of the service provider and how efficiently the partner has solved the problems of clients.
  3. Visit individual providers:Most of the Pharma companies after identifying few potential service providers visit them individually. In the course of meeting they analyze the working environment, management process, IT capability and quality assurance procedures of the service providers. According to the Pharma companies, this practice gives them a clear picture of the quality of the services that will delivered by the respective providers.
  4. Check financial stability:If possible, companies looking to outsource regulatory affairs check the financial stability of the service provider and obtain copy of audit reports.
  5. Formulate standard Service Level Agreement (SLA):Pharma companies while formulating SLA make sure that elements like service required and expected standard of services, delivery time, responsibilities of provider and clients, payment terms, measures to resolve disputes, confidentiality and non-disclosure provisions and termination conditions are clearly specified.
  6. Choose partner who provide value for money:The companies choose a partner who “fits for the purpose” and whose capabilities match their outsourcing needs.
  7. Measuring of success:Pharma companies measure the benefits of outsourcing both in terms of financial benefits as well as in terms of meeting the legal and compliance requirements.

These seven practices have proved effective in striking successful relationship with regulatory outsourcing vendors.




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