Kinesys Consulting provides
regulatory affairs consultancy for the
pharmaceutical, biotech and medtech industries.
Our expertise includes the development
and registration of small molecules and
biotech products for established and niche
therapeutic areas.
Our experience extends to orphan drugs, medtech projects, and other innovative
products (e.g. stem cell and other cell therapies, drug re-profiling, drug device
combinations, novel diagnostics). We intervene in the product cycle from early
non-clinical and CMC development to registration, and also provide support to
marketed products.
Our therapeutic area expertise is both extensive and, in many areas, profound,
including oncology, metabolic diseases, CNS, anti-infectives, recombinant haematology
products, inflammation.
Regulatory and product development strategy
Design of early development “proof
of concept” and full development
programmes
Orphan Drug Designation and development
in EU and USA
Scientific Advice and Protocol Assistance
Clinical Trial Applications
CTD-summaries/overviews
Meetings with Regulators (EMA,
EU National Agencies, FDA)
Marketing Authorisation Applications (Advice on and assistance with preparation
and submission of Mutual Recognition, Decentralised
or Centralised filings and US NDAs)
Regulatory Due Diligence
Estimates and proposals are
provided rapidly and without obligation.
