Kinesys Consulting provides
strategic development and 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. drug re-profiling, drug device combinations, novel diagnostics).
We
intervene in the product cycle from early non-clinical development to registration,
and also provide support to marketed products.
Design of early development “proof
of concept” programmes
Design of full development programmes
Orphan Drug Designation and development
in EU and USA
Scientific Advice and Protocol Assistance
Regulatory and product development strategy
Clinical Trial Applications
CTD-summaries/overviews
Meetings with Regulators (EMEA,
EU National Agencies, FDA)
Marketing Authorisation Applications (preparation
and submission of Mutual Recognition,
Decentralised
or Centralised filings)
Regulatory Due Diligence
Estimates and proposals are
provided rapidly and without obligation.
