Outsourcing has become an increasingly common practice in the Pharma and Biotech industry more so in the area of regulatory affairs and Pharmacovigilance. Regulatory outsourcing has now become a norm as most companies are seeking partners to manage operational tasks including report publishing and submission publishing.

Large and small life sciences companies now turn to outsourcing vendors to manage tactical tasks and help adopt best practices. It is learnt that good partnerships offer efficiencies in terms of greater market share and skills and capabilities that enable products to be brought to market more rapidly in diverse markets.

Nonetheless one must consider if the benefits of outsourcing outweigh the costs and one should be discreet in selecting the consultancy or supplier. In 2013, regulatory writing and publishing services segment amounted to 40% of the total regulatory affairs outsourcing market. The regulatory consulting and legal representation services segment is expected to have the fastest growth rate of over 14% from 2014 to 2020.

Since 2013, the biopharmaceutical manufacturing market has shown improvement; traditionally the healthcare sector has been fairly insulated from adverse financial events.Post-recession period has seen a rise in budgets in areas that help improve performance of manufacturing activities and other areas of productivity and cost-savings.


Outsourcing entails in delegation of responsibilities among different manufacturers. The FDA Guidance to Industry – “Quality Systems Approach to Pharmaceutical CGMP Regulations,” defines outsourcing as, “the hiring of a second party to perform parts of the overall manufacturing process.” These specific legal arrangements pursue a goal: lower manufacturing costs and use of advanced technology to meet a specific manufacturing milestone.

Outsourcing brings products to the market faster with fewer costs required to develop, qualify and then implement all the manufacturing processes than the parent company. A large number of companies are turning to partners to manage operational tasks, including report publishing and submission publishing. Some companies have engaged partners to assist with submission planning and regulatory data management.

In the future almost all aspects of regulatory operations, with the exception of dossier management may be outsourced. Regulatory leaders from several major companies say establishing the regulatory strategy and managing the interaction with the agency will remain in-house.


Companies need a long-term relationship with potential service providers’ which is the basis for outsourcing to create a successful partnership


  • Does it have the requisite experience and expertise?
  • Does it have the necessary global reach?
  • Does it have a track record of service commitment?
  • Has it been recognised within its own industry?
  • Does it track customer satisfaction levels?
  • How good are the service level agreements it offers?


  • Good relationship management is critical for the business?
  • Is it prompt in replying from the outset?
  • How will the organization’s relationship be managed? Is the approach both personal and professional?
  • How good and available is the contact(s)?
  • How does it propose to report progress?

Outsourcing may involve distance and time zone differences and make interaction more challenging. Companies must take into consideration language barriers and different business cultures including the impact of exchange rate fluctuations particularly in the current global economic circumstances. Regulatory Affairs Market Outsourcing can be categorized into two segments.


  • Regulatory Affairs
  • Clinical Trial Applications and Product Registrations
  • Regulatory Writing and Publishing
  • Regulatory Consulting and Legal Representation
  • Others (Post Approval Maintenance, Reimbursement Consulting etc.)


  • North America
  • Europe
  • Asia Pacific
  • Rest of the World (RoW)


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