NDA has a unique team of former regulators and scientists with first-hand experience of the regulatory standards and development priorities for complex biopharmaceutical products.
Download further reading about our Biologic services.
Obtaining a good balance between ground-breaking science and an appreciation of the commercial opportunities needed for a company to succeed is a challenge to any company developing biological/biotechnological products. Coupling this with financial pressures, decisions on which molecules to progress through development, complex and costly R&D, and resourcing challenges can all impact upon a biotech and biologics company’s success. Strong independent scientific, technical and commercial advice from the outset can significantly improve the chances of success.
Our team of experts have been involved in numerous biotech development programmes for companies based across the globe. They understand the core decisions needed to be made to get a biotech product through development, including the required non-clinical studies, authorisation and post approval requirements in the US and EU. This means you can tap into NDAs scientific, strategic and technical knowledge and expertise from lead candidate selection stage, onwards.
Our track record
NDA has supported more than 65% of the world’s top 20 biotech companies with their development programmes, as well as 50% of all biologic products approved EU and US in 2014 during their development programmes.
How we help
NDA can support you in preparing development plans for all types of biological/biotechnological molecules. We can support you throughout development, including:
- Preparation of development plans for all types of biological molecules
- Optimisation of molecular format, including minimisation of immunogenic potential
- Strategic support for the choice of expression systems
- Definition of target product quality profile
- Manufacturing process control, characterisation studies, choice of analytical and bioanalytical methods method validation, including bioassays
- Strategic advice on comparability studies and analysis of comparability data
- Non-clinical and clinical study design to support a global registration strategy
Our advice is strategic, yet our team’s approach is very hands-on.