Pharmacovigilance
NDA’s integrated Pharmacovigilance and Risk Management Services give your company access to a comprehensive understanding of the clincial safety requirements throughout the entire life cycle of your product. This provides a number of critical advantages to your business:
- Reducing the risk of MAA rejections and product withdrawals, thereby saving time and money,
- Increased efficiency by ensuring that you do things right first time,
- Faster and less costly time to market through the use of efficent processes, tools and decision making.
Product Life Cycle Management
By examining your product from an integrated life cycle perspective, NDA makes the complexities of increasing and varying regulatory requirements more manageable.
As the product moves through its different life cycle phases different sets of competencies, processes, systems and tools are required to efficiently deliver satisfactory results. NDA’s experts have a wide range of knowledge and competencies required to address issues in all phases of a product’s life cycle.
Not only does NDA provide expert and specialist knowledge, but as the need for hands-on work increases, NDA provides resources to manage your pharmacovigilance initiatives as well. Integrated Pharmacovigilance and Risk Management Services
Throughout the product life cycle, a strategic partner with intimate knowledge of regulatory requirements will prove to be a critical success factor.
- NDA provides strategic advice and assistance analysing safety requirements and helping you set up your pharmacovigilance frame work.
- NDA assists you in preparing a detailed description of your pharmacovigilance system and producing Risk Management Plans and Periodic Safety Update Reports.
- Working with NDA promotes company wide understanding of pharmacovigilance requirements.
- NDA assists you with your audit preparations, including providing a full third party audit of your procedures, facilities and processes.
- NDA helps deliver:
- clearer directives,
- smoother processes,
- increased safety awareness.
Ultimately this leads to compliance with requirements and facilitates the swift introduction of your product on to the market and the continual monitoring of it once it is there.
Once on the market, NDA’s knowledge of post marketing safety helps you maintain and develop an in-depth understanding of your product’s safety profile. |
