Regulatory Affairs Consulting Services

Have you got a project or study
that requires skilled
regulatory staff urgently?

Regulatory Affairs

Proclinical’s regulatory outsourcing services offer companies the opportunity to outsource entire departments with the added benefit of an effective project management structure. With the strain of resourcing taken away, the existing workforce can focus its efforts on other areas that promote company growth, such as product development and improving processes, while the interim function gets to work independently. Our combined recruitment and regulatory expertise enables us to design an outsourcing plan that fulfils the company’s individual needs and is tailored to its business objectives, strategy and future vision.

Regulatory strategy services

  • Global regulatory affairs
  • Submitting multi-layered NDAs, MAAs and CMC support
  • Executing label changes across several countries
  • Managing the ebb and flow of regulatory needs as you grow
  • Project Management
  • Regulatory Operations

Regulatory CMC services

  • CMC strategic development consulting Phase I to III
  • Strategy throughout entire product lifecycle management
  • Gap analysis to comply with global regulations
  • Operational assistance with multiple CMC components e.g. NDAs, MAAs, INDs, BLAs, ANDAs and IMPDs
  • Analysis, preparation and submission of post-approval change control
  • Preparing and attending health authority meetings
  • DMF preparation, submission and maintenance
  • Assistance with requests for information and responses to regulatory agency comments concerning CMC
  • Due diligence of potential product acquisitions (CMC) and of suppliers

Supply Chain Optimisation/Technology Transfer

  • Gap analysis
  • Assistance with the selection of CMOs
  • Registering new site manufacturing
  • Assistance with increased regulatory burden
  • Identification of risk register
  • Creation of staff augmentation model
  • Writing transfer protocols
  • Formation of technology transfer plan
  • Provision of Subject Matter Experts (SMEs)

Benefits include:

  • Highly skilled and experienced turn-key specialist teams
  • No scope of work too big or small; outsource a single project or several across multiple products
  • Dedicated point of contact and program governance meetings
  • Efficient and a flexible alternative to permanent hiring, with added benefit of focussing
  • on in-house staff on core growth activities
  • Reduced time and costs compared to resourcing contingency or employed workers
  • Choose which services to outsource
  • Rapid start-up process
  • Tailored solutions for programme management, timeline tracking, and billing
  • All CMC needs taken care of in one place: Both Pre and Post approval support
  • Expert CMC quality investigation and problem resolution
  • Scalable resourcing model results in cost effective and efficiency improvements of 20 –30% while dealing with supply chain rationalization and Mergers and Acquisitions
  • Experienced support with health auroty meetings and interactions

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