Electronic Regulatory consulting

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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.

Electronic publishing
Medical Devices
Cosmetics
Borderline Products
European Regulatory Affairs for US companies

Helping you with electronic submissions

Since the 1st January 2009 the EMEA has recommended
electronic-only submissions with eCTD. This applies to both new
and existing submission types. Rapporteurs and CHMP members will not receive paper copies.

From 1st July 2009, paper and other (non-eCTD) electronic formats will only be received by the EMEA as an exception. Rapporteurs
and CHMP members will not receive paper copies or other
electronic formats.

What can PDS do for you?

• We perform eCTD readiness assessments (for your company's
   in-house working process and template review)
• We manage the entire product submission process from conception    to retirement, tailored to your needs, for preparing, converting    and/or updating documents for submission, within EU or USA
• We use a validated, proven eCTD software package for compilation    of regulatory submissions and publishing
• We can convert your legacy documents and ensure their eCTD    readiness and ICH compliance

Benefits include:

• Your products go to market faster
• Reduced costs/resources/time needed to plan, locate and    assemble regulatory content
• Better coordination/collaboration by sharing a single, central    resource
• Web interface to view/review dossier as it is built Secure, fully    compliant and validated

We perform eCTD readiness assessments (for your company's in-house working process and template review)

We manage the entire product submission process from conception to retirement, tailored to your needs, for preparing, converting and/or updating documents for submission, within EU or USA

We use a validated, proven eCTD software package for compilation of regulatory submissions and publishing

We can convert your legacy documents and ensure their eCTD readiness and ICH compliance

Regulatory Affairs - Electronic publishing

your fast track to market