Supporting you with Regulatory Affairs, Worldwide

Regulatory Affairs

At Kinapse we understand the competitive environment in which our customers operate: wide-ranging commercial demands, competing priorities, cost pressures and increasing regulatory stringency all have an impact on the regulatory functions in pharmaceutical, biotechnology, biosimilar, orphan drug, vaccine, device and diagnostic businesses.

The Kinapse Regulatory Affairs team is ideally placed to offer you a full Regulatory Affairs support service. Our service offers the unique combination of in-house expertise in Regulatory Affairs, CMC and Publishing that is strengthened by an established network of Consulting Partners: experts in many markets who bring specialist and in-depth understanding, and, where needed, local market intelligence to your project.

The Kinapse Regulatory Affairs Service ensures you benefit from the process rigour of a global management consultancy but with the specialist expertise of hands-on regulatory professionals with a broad understanding of the life sciences development and commercialisation value chain.

Thanks to this unique combination of insights, we help our clients to optimise regulatory activity. We provide organisational solutions which are robust, pragmatic and well-supported by partner functions:

  • Organisation and interface design (for global, regional and local teams)
  • Assessment and development of resourcing and outsourcing strategies, including resource modelling and vendor management
  • Productivity consulting
  • Process redesign
  • Performance management including scorecards & benchmarking
  • Project and change management

We provide you with the results that matter:

  • Timely and full approvals and maintenance of regulatory submissions
  • Local knowledge, cultural understanding and personal contacts in emerging as well as developed markets
  • Regulatory services cost-efficiently outsourced

Pragmatic, hands-on support for your in-house Regulatory teams: that’s the Kinapse difference. We are Kinapse…

  • Content definition and submission strategy - all submission types, all regions and all product lifecycle stages
  • Expert-reviewed submissions
  • Pre-filing liaison with regulatory authorities
  • Document management and publishing: paper, NeeS and eCTD publishing
  • Depending on your need, we can:
    • Work with local affiliates and agents, to provide you with local submission support and case management
    • Call on our expanding global regulatory network spanning 95 countries and a team of individuals who can provide local regulatory intelligence, support local submissions and engage with local regulatory authorities on your behalf

Regulatory Services
At-a-glance: The Kinapse Pre-submission Service:

  • Regulatory Affairs support (CTAs, IMPDs, INDs, NDAs, MAA, global registration submission)
  • CMC Authorship (CTAs, IMPDs, INDs, NDAs, MAA, global registration submissions)
  • Regulatory Affairs and CMC strategic guidance
  • Publishing support – all submission types and format, and reports
  • Regulatory Intelligence
  • DMFs
  • EDQM Certificate of Suitability applications
  • Stability data assessments
  • Territory-specific site registration applications (including GMP certificate applications for Turkey)

At-a-glance: The Kinapse Post-Submission Service:

  • Regulatory Affairs support across the lifecycle (variations, renewals, annual reports)
  • CMC Authorship across the lifecycle (variations, renewals, annual reports)
  • Regulatory Affairs and CMC strategic guidance
  • Publishing support – all submission types and format, and reports
  • Labelling
  • Regulatory Intelligence
  • PSURs
  • Site rationalisation regulatory support
  • Stability Data Assessments
  • CTD Conversions (content and format)

System experience includes: Documentum, TrackWise, the ISI Publishing suite (ISI Publisher, eCTDXPress, ISIToolbox), Lorenz, EURSvalidator, PharmaReady, labelBridge 1.5, Oracle Clinical, Extedo, Liquent systems, and Tarius.

We are Kinapse….

Advise · Build · Operate