Our Regulatory Affairs Capability and Experience

Hand-picked Regulatory Affairs specialists with a wealth of hands-on regulatory experience particularly at the strategic and tactical level.

Strategic/ operational drug development planning
NCE/ line extensions/ devices/ diagnostics
Rx/OTC products
Biologicals
Scientific advise, including dossier preparation, strategic planning and management of the meetings
Regulatory authority negotiations during development
e CTD and dossier creation, including publishing
Regulatory writing, overviews and summaries
Broad geographical reach
Senior Health Authority people knowledge, in particular US, EU, China, Singapore, and Australia
All Therapeutic Areas, biologics and small molecules
Information management
US leadership
Low cost operational support (eg India)
Clinical study analyses and report creation
UK leadership in the EU
Due diligence

Alliances

Information management: Verinume (www.verinume.com)
Regulatory Affairs: Raifarm LLC Russia
Clinical Research: Pacific Clinical Research CRO (www.pacificcro.com ) ; clinical studies across all Asian countries(except Japan); headed by a pioneer in Asian clinical research, Robert Teoh, MB,BS,MD, FRCP.”
Electronic publishing
Clinical study analyses and report writing : Kinapse (www.kinapse.com)
Early development: Chrysalis Pharma Partners USA (www.chrysalispharma.com) led by Jim MacDonald, PhD, 30 years plus Industry leader in toxicology and early drug development in Merck and Schering-Plough.
Services: Assure the participation in the early development process of individuals with appropriate experience in the drug development process and expertise in the necessary areas to assure success to the next milestone. The capabilities that either exist within the Core Partners or will be brought in with expert consultants includes: Toxicology, Clinical Pathology, Anatomic Pathology, Genetic and Reproductive Toxicology, Bioanalytical (method development and validation), Toxicokinetics, Drug Metabolism (including all aspects of ADME studies), Medicinal Chemistry, Pharmacokinetics and PK/PD modeling, biomarker development, Clinical Pharmacology and Exploratory Medicine. The individuals that will support Chrysalis Pharma Partners in these disciplines have had significant experience in big pharma usually holding senior level positions in these key disciplines. These experts are also available to RegAff.’

Regulatory Affairs Resource Network Functional

Functional	Experience level
CMC	Director/Manager level
Pre-clinical	VP/Director/Manager level
Director level	VP/Director level
Clinical	Compliance

Regulatory networked to independent regulatory consultants
Alliances with small specialist regional regulatory consultants