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Integrated Services

NDA develops professional services with one goal in mind - to facilitate that patients get access to good medicines faster.

Through a unique integration of professional services, NDA bridges the communication gaps within pharmaceutical organisations as well as between the company and the regulatory agencies. The end result - a completely integrated service of a quality unmatched in the industry - is used by the world's top pharma companies to speed up their market introduction and to optimise product maintenance.

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NDA Services

Through the provision of professional services from some of Europe's leading regulatory experts, NDA holds a unique position to help deliver innovative and life improving medicines into the European market place.

NDA maintains and continues to expand on its comprehensive portfolio of services aimed at providing clients from all over the world with an ever up-to-date vision of current regulatory requirements and of the latest industry trends.

From advice on drug development and regulatory strategy to operative on- or off-site support, NDA’s portfolio of services is driven by the following set of key beliefs:

Product development and market introduction substantially benefit from an excellent industry know-how and a carefully planned regulatory strategy early on in the product life-cycle.
The provision of regulatory advice and services is competence dependent, demanding longstanding experience of regulatory procedures as well as cutting edge know-how on current policy, trends and future development of requirements.
Value increases through the consolidation and integration of information from multiple subject areas, enabling clients to examine their product strategy from all available perspectives.
Decision making without careful consideration of the aspects represented within each of these areas will be prone to error, thereby increasing the time to market and ultimately the time it will take for the product to reach the patient and to generate a profit.

NDA provides the best advice and strategic and operational support available in the pharmaceutical market, thereby ensuring predictability, reduced risk and costs, a fast market introduction and a reliable product maintenance process.

The NDA Group is an independent consulting organization delivering services within outcome oriented drug development focused on the strategic and operational aspects of regulatory affairs. NDA provides assistance to both the Pharmaceutical Industry as well as Regulatory Agencies. The ultimate objective of NDA is to help to develop better medicines that reach the patient without unnecessary delay. NDA achieves this objective by critically reviewing client project development plans with the aim that they are optimized to meet the needs of regulatory authorities and then to help to implement those strategies. NDA strives to bridge the communication gap between "the regulators" and "the regulated" to the benefit of patients.

The NDA Group provides services within several different areas such as regulatory affairs, pharmacovigilance and patient safety and quality assurance. NDA's regulatory consultants have extensive knowledge and experience working with traditional pharmaceuticals, biopharma, medical devices and production processes within the pharmaceutical industry.

The NDA Group also provides expert and strategic advice on development and regulatory strategies and assists the pharmaceutical industry with qualified training.