Product Lifecycle

Pre-submission

Pre-submission Phase

By focusing your attention on what’s needed to get your drug approved by the regulators and reimbursed by the payers, we’ll help you optimise your development program and make you aware of additional requirements.

Regulatory

Example of services

  • Full Regulatory Review and Support
  • Advisory Board Support and Review
  • Scientific Advice / Protocol Assistance Preparation
  • Paediatric Investigation Plans
  • Orphan Drug Designation Application
  • SME support for non-EU companies
  • Regulatory Support for Clinical Trial Applications
  • Pre-IND/IND submissions
  • PRIME Applications

Understanding and taking the regulatory reality into account, enables you to focus on the right end-points that are more likely to gain approval by the regulatory authorities. It also ensures that you focus your attention on the right activities to get your product to a patient – saving you costs, time and resources and increasing your chances of success.

NDA provides clients with strategic input and guidance from the very early stages of drug development, from high level support, to regulatory project management and delivery of key documents (including scientific and medical writing).

Pharmacovigilance and Quality

Example of services

  • Auditing
  • QPPV
  • Pharmacovigilance Lifecycle Management
  • Authoring and Process Development
  • Drug Safety Update Reports

With the introduction of the 2012 Pharmacovigilance Legislation, the emphasis on risk management and monitoring has been greatly emphasised. Ensuring that your development program uses a risk- based approach enables you not just to meet regulatory requirements, but will also allow you to develop a program that targets the most relevant areas of risk. This ensures valuable resources are used where it makes the most sense.

NDA provides clients with strategic input into the management of patient risks in clinical programs. High-level expertise and input, paired with process development and a solid infrastructure and toolset, ensures that your risk management efforts are efficient for bringing your products to market, and stay there.

HTA (Health Technology Assessment)

To ensure your new medicine will gain approval from local country authorities and health bodies, it is important to factor in their needs and requirements as early as possible in the pre-submission stage.

With the help of the experts of the NDA Advisory Boards – many of whom helped shape the regulatory and HTA systems prevalent in Europe today, – you get access to the following  services.

Modelling and simulation of payer acceptability/regulatory approvability of a new medicine in the discovery phase or late development phase

Joint regulatory/HTA advice to align the clinical development to generate evidence for regulatory approval and HTA acceptability. NDA have successfully assisted companies over a two year period and built up extensive experience in this area. This advice does not replace formal parallel consultations between regulators and HTA bodies in the EU but as complementary to any formal advice. It is, preferably sought prior to gaining formal scientific advice, in order to help defining the areas and positions covered.

NDA will provide an opinion on company’s questions before any formal regulatory/HTA scientific advice. It is crucial to formulate the right questions before such advice and support those with good rationale. NDA will help you get the questions to focus on the ‘right’ issues to a minimise the risk of getting misguided advice.

Before the regulatory submission, companies need to prepare the risk management plans.  This includes proposals on how to perform post authorisation studies to follow up safety and efficacy. It also needs to be ensured that risk minimisation plans are working during real life use of the drug.  At a later stage, HTA, pricing and reimbursement agencies also request evidence generation in real life use with studies that could generate this kind of information.  Huge savings could be achieved if both types of studies are designed and performed to generate information satisfying both payers and regulators.  NDA will assist you to develop a strategy to develop post authorisation studies with this in mind.