Post Authorisation Phase
It is only once a product has been approved and introduced to the market that its value can be realised. By ensuring that your product is managed in an efficient and competent way, we assist you and patients get the best out of your product.
Example of services
- Publishing and Regulatory Life Cycle Management
- On-Site Placements
- OTC Switching
- Established Product Support
- Post Authorisation Maintenance
It is not until a product reaches the patient that it starts delivering on its promise, both to the patient and company. It is critical that established products are properly maintained once it is on the market.
NDA provides the best possible insights to ensure your product stays on the market and can be efficiently maintained following approval. We support you through manufacturing changes, new market introductions, renewals and variations.
Our team can support you in finding new opportunities for your products through alternative options like switching to Over-the-Counter (OTC) designation or advising on including new indications or routes of administration.
Pharmacovigilance and Quality
Example of services
- Safety Monitoring and Database
- Signal Detection and Analysis
- Pharmacovigilance Authoring and Process
- Pharmacovigilance Audits
- All sorts of PRAC interactions including Article 31 and 107 safety referrals
The new pharmacovigilance legislation introduces many new requirements for established products, to be implemented before July 2015. You now need a consistent system to store all your safety feedback data to enable potential signals to be more easily spotted.
Once these systems are in place, you then need the right people to detect and analyse the signals to spot any emerging issues before they are published by the EMA.
NDA has a comprehensive range of services to monitor the safety of your product. We can assist you in transitioning and complying with the new legislation. We can also provide you with an experienced Qualified Person (QPPV) as required.
We also manage the full monitoring and data collection process, from adverse reaction to signal detection and analysis. Plus, we can assist in authoring key documents design or rework critical processes so you can be rest assured you are compliant with the regulatory requirements.
HTA (Health Technology Assessment)
You have your product approved by the regulators and your approval for HTA, reimbursement and pricing agencies in the EU. Now you need to live up to your post approval commitments, from the regulators and payers, and be prepared for reassessment from the payer.
The generation of real-life evidence needs well-performed studies to be completed in a rational and cost effective way. A major problem will be getting access to patient information and databases for these kinds of studies. Through NDA’s network and expertise, we can advise how to best overcome this hurdle.
Reimbursement and pricing decisions are constantly under reevaluation by different bodies around the EU. NDA will assist you in complying with, then developing the value file for these assessments.