Regulatory Affairs
NDA’s integrated Regulatory Services give your company access to a comprehensive understanding of regulatory requirements throughout the entire life cycle of your product. This provides a number of critical advantages to your business:
- Reducing the risk of Marketing Authorisation Application rejections and product withdrawals, thereby saving time and money
- Increased efficiency through regulatory compliance from Day 1 of the product life cycle
- Faster and less costly time to market through the efficient application of regulatory strategy, aiming at the right targets
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 your product moves through its different life cycle phases different sets of competencies, processes and tools are required for the efficient delivery of 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 initiatives. Integrated Regulatory Services
Throughout the product life cycle, a strategic partner with intimate knowledge of regulatory requirements can prove to be a critical success factor.
- NDA provides strategic advice analysing regulatory requirements and helping to create your regulatory plans considering aspects such as:
- the science behind your product,
- paediatric investigation planning,
- protocol design,
- clinical end-points and
- orphan drug designations.
- NDA acts as a guide from early clinical trial phase, and through the Centralised, as well as the Decentralised and Mutual Recognition Procedures, ensuring a significantly higher chance for approval.
- NDA provides full Regulatory Support:
- all current filing methods - eCTD, NeeS, paper,
- efficient production and design of packaging and fully tested patient leaflets,
- continued regulatory compliance through line extensions and variations.
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