scroll left
scroll right
|||||||||||

 

Janet Ellis
Regulatory Affairs Director

"I've handled the regulatory affairs of products from the biotechnology, pharmaceutical and complementary therapy industries including vaccines, novel dosage forms, generics, OTC products, herbal and homeopathic medicines, food supplements and borderline products.

I've project managed a wide range of submissions including EU mutual recognition, centralised and national marketing authorisation applications, clinical trial applications and submissions to Ethics Committees and has handled applications to regulatory authorities in Europe, The Middle and Far East, South America, Asia and Australasia."

Janet has a background as a pharmacist, with a PhD in pharmaceutical microbiology from the University of Nottingham.

pharma development

pds

Adverse event tracking
Biotech QC specialist
Clinical trials manufacturing
Contract QP
Contractor management
PAI preparation
Electronic publishing
eCTD systems
GXP auditing
Herbal medicines
Inspection preparation
Interim management
Laboratory management
Medical device registration
New product introduction
Outsourcing
Packaging and labelling
Particle science
Pharmaceutical development
Project management
Quality management
Qualified Person services
QP certification
QP release
QP support
Regulatory affairs
Regulatory due diligence
Training and development