Regulatory Affairs, CMC and Publishing

To keep up with the dynamics of an increasingly challenging regulatory environment, life sciences companies’ Regulatory Affairs groups are grappling with competing priorities under increasing cost pressure and external scrutiny.

Increasing stringency of regulation in traditional markets

Regulatory Affairs groups are challenged to work harder to deliver timely and full approvals as well as maintain compliance for established products.

Commercial strategy demanding access to emerging markets

Regulatory Affairs groups must ensure local knowledge, cultural understanding and personal contacts in emerging as well as developed markets.

Industry-wide cost pressures

Regulatory Affairs groups have to efficiently deliver routine processes while freeing up senior people to support the case for medical and economic added value.

Kinapse works across all Regulatory Affairs capabilities and at the key interfaces to improve performance

Kinapse is well placed to provide these services because we:

  • Bring deep experience in key Regulatory business processes from within major global pharma companies, understanding from the inside the imperatives and constraints within which our clients operate
  • Understand through our own coverage of the pharma development and commercialisation value chain the needs of our clients’ internal stakeholders
  • Blend onshore expertise and customer-liaison with cost-effectiveness of offshore in our innovative operating model, delivering quality and compliance in a cost-constrained environment
  • Tailor processes and outputs to our client’s specific requirements, so routine processes are executed cost-effectively, driving increased productivity and enabling internal expertise to target higher value activities

Examples of projects include:

Consulting:

  • Organisation design (for global, regional and local teams)
  • Assessment and development of resourcing and outsourcing strategies
  • Process redesign
  • Emerging market strategy development
  • Performance management design, tracking and analysis

Outsourcing:

  • Submissions strategy, planning and project management
  • Quality checking of the full range of regulatory submissions
  • Authoring and document preparation for all submissions across lifecycle
  • Source transfer and rationalisation strategy and execution
  • Supportive global regulatory intelligence gathering and requirements management across all global markets
  • Submissions publishing for all paper and electronic formats using a wide range of tools

The following are Senior Members of our Regulatory Affairs team: