Alliances
With our proven track record of more than 22 years in the consulting business,
we are well established within the life science industry and have an extensive and
valued client base. In particular, our reputation is recognised in the areas of
strategic regulatory affairs and those aspects of product development that are
peculiar to biologics. Accordingly, our team is qualified and experienced in issues
relating to genetics, cell biology, manufacturing and control of biotech and related
products, as well as non-clinical and clinical development.
The evolving environment in which we work requires an ever more interdisciplinary approach to projects, into areas of expertise that are not covered by our company. Through ERA's combination of experience and network of contacts within the biopharmaceutical industry we are able to identify and recommend external, specialist experts either to work with our own team members on your project, or to address any additional needs, for example in the following areas:
- Contract manufacture of biological products
- Laboratory services for cell line qualification and testing
- Virological studies including clearance and inactivation studies
- Regulatory input for the medical device component of combination products
- Legal advice on intellectual property and licensing
- Compliance audits
- Pharmacovigilance
- Pricing and reimbursement
- Biostatistics
- Regulatory support in regions outside of Europe, the USA or Australasia