Medical Drug Supplies Ltd has a team of very successful and professional regulatory experts to help in registering your product (API, Finished product, generic application, duplicates, parallel import application, OTC etc) in EMEA countries
Regulatory Procedures

Our services include the following:

Medicinal products:

		Clinical trial submission
		MA submissions
		National submissions
		Mutual Recognition Procedures
		Decentralised procedures
		Centralised procedures
		Orphan Medicinal Products

Cosmetics

		Labelling
		Dossier preparation
		Liaise with Agencies

Chemicals

		Labelling
		Liaise with Agencies

Maintenance

In the Post-approval phase we offer to:

		Act as National regulatory dept. and handle entire life cycle management of your company products
		Act as primary contact for product complaints and recalls.
		Act as QP for wholesaler dealer
		Handle Pharmacovigilance

Translation
We can arrange professional quality translations into all official European languages through our network of regulatory consultants.

User testing

We perform Readability testing of Patient Leaflets.
The test is performed in accordance with:

		EFPIA. General Recommendations for Readability User Testing of Package Leaflets for Medicinal Products for Human Use – Version March 2003.
		MHRA Guidance on the User Testing Patient Information Leaflets- Version June 2005.
		A Guideline on the Readability of the Label and Package leaflet of Medicinal Products for Human Use (European Commission, January 2009).
		Handle Pharmacovigilance

Our readability studies have been used and accepted by Member States in Mutual Recognition and Decentralised Procedures throughout Europe.

eCTD

Applicants have had the opportunity to submit in eCTD format together with a paper submission (CTD). Now, several countries no longer allow paper submissions of marketing applications as they only accept electronic submissions. Electronic submission is to become mandatory. Our regulatory team can support conversion from CTD to eCTD to establish an electronic baseline and compile subsequent submissions in eCTD format.

Pharmacovigilence Services
Medical Drug Supplies Ltd can support your company to use our cost effective extensive pharmacovigilence services.
We can undertake following services:

Reporting of Individual Case Safety Reports

Literature search

QP Services

PSUR/Periodic Report submission