About Nda group ab
Nda Group AB: Streamlining Drug Development for Faster Patient Access to Medical Therapies
Nda Group AB is a leading consulting firm that specializes in regulatory affairs and drug development. The company was founded in 1994 with the goal of helping pharmaceutical companies navigate the complex regulatory landscape and bring new drugs to market faster. Today, Nda Group AB has offices in Stockholm, London, Munich, Princeton, and Tokyo, and serves clients around the world.
At Nda Group AB, our mission is to streamline drug development in order to accelerate patient access to important medical therapies. We believe that every patient deserves timely access to safe and effective treatments for their medical conditions. That's why we work closely with our clients throughout the drug development process – from early-stage research through clinical trials and regulatory approval – to ensure that their products meet all necessary requirements for safety, efficacy, and quality.
Our team of experts includes scientists, clinicians, regulatory specialists, pharmacists, statisticians, project managers and other professionals who have extensive experience working with global health authorities such as FDA (US), EMA (EU), PMDA (Japan) etc., as well as local agencies across different regions worldwide. We provide strategic advice on all aspects of drug development including preclinical studies design & execution; clinical trial planning & management; data analysis & interpretation; dossier preparation & submission; post-approval activities such as life-cycle management etc.
We offer a wide range of services tailored specifically to meet each client's unique needs:
Regulatory Strategy: Our team provides strategic advice on how best to navigate the complex regulatory landscape across different regions worldwide. We help clients develop comprehensive plans for product registration based on scientific evidence while considering commercial objectives.
Clinical Development: Our experts provide guidance on designing efficient clinical trials that generate high-quality data while minimizing risks associated with study conduct or protocol deviations.
Pharmacovigilance: We help clients establish robust systems for monitoring safety signals during clinical trials or post-marketing surveillance activities so they can respond quickly if any adverse events occur.
Medical Writing: Our experienced writers prepare high-quality documents such as protocols or reports required by health authorities during product registration processes globally.
Quality Management Systems: We assist companies in developing quality systems compliant with international standards like ISO 9001/13485/14971 etc., which are essential components of successful product registration processes globally.
Training Services: Our training programs cover various topics related to drug development including GCP/GLP/GMP regulations compliance training courses designed specifically according client’s needs
At Nda Group AB we pride ourselves on delivering exceptional service at every stage of the drug development process. With over two decades of experience working with pharmaceutical companies around the world we have developed an unparalleled understanding of what it takes not only get your products approved but also how best position them within competitive markets once they are launched commercially.
Why Choose Nda Group AB?
There are many reasons why you should choose Nda Group AB when looking for a partner in your journey towards bringing new drugs into market:
Expertise - With over two decades' worth experience working within this industry sector we have built up an unrivalled level expertise when it comes navigating complex regulations governing global healthcare markets today;
Global Reach - With offices located across Europe North America Asia Pacific region means no matter where you are based there will always be someone available locally who can support your business needs;
Tailored Solutions - At NDA group ab we understand each client has unique requirements therefore our solutions are tailored accordingly ensuring maximum efficiency whilst maintaining highest levels quality standards;
Innovative Approach - As part our commitment continuous improvement innovation remains core value driving force behind everything do here at nda group ab;
Collaboration - Working together collaboratively key success factor any project undertaken by us whether it be small scale consultancy engagement large-scale multi-year program delivery initiative.
Conclusion
In conclusion,NDA group ab is one-stop-shop solution provider offering end-to-end services covering entire spectrum from early-stage research through clinical trials until final marketing authorization granted by relevant health authorities globally.We pride ourselves delivering exceptional service every stage journey towards bringing new drugs into market.Our team experts includes scientists clinicians pharmacists statisticians project managers other professionals who have extensive experience working global health authorities such FDA EMA PMDA etc.,as well local agencies across different regions worldwide.We believe streamlining drug development process accelerates patient access important medical therapies ultimately improving lives millions people around world.Choose us today let us help make difference!
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