Donawa Lifescience Consulting: Device Regulatory - Clinical Studies

DEVICE CLINICAL STUDIES
IN EUROPE AND THE US:
REGULATORY FRAMEWORK
AND BEST PRACTICES

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One-Day Seminar
Wednesday 16 June 2010
ROME, ITALY

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EU/US Pharmaceutical Services

Your partner throughout the entire drug development and marketing authorization processes

Pharmaceutical services
Donawa Lifescience Consulting (DLC) provides tailored assistance to pharmaceutical and biotechnology companies for meeting European and US requirements, including those subject to the recent European ATMP Regulation.

EU regulatory strategy and marketing authorization
DLC can help formulate effective regulatory strategies for new drugs, in addition to advising which authorization process (centralized, decentralized, mutual recognition or national) best suits your development and marketing plan. We can also help prepare scientific advice requests with the European Medicines Agency (EMEA).

EU clinical trial authorizations
DLC is an experienced full service European CRO and can help meet national regulatory authority and site-specific requirements. We also provide expert management and monitoring of clinical trials. See our dedicated CRO website.

US regulatory strategy, INDs and NDAs
Selecting the most applicable submission type is a critical element of an effective regulatory strategy. DLC can assist with INDs, NDAs, ANDAs, BLAs, and e-CTD submissions, in addition to attending pre-IND meetings.

US GMP compliance

DLC has an experienced ex-FDA field investigator available to help ensure your systems meet the relevant US GMP requirements.

The DLC pharmaceutical service is managed from our office in Nyon, Switzerland. Contact us either by e-mail for a confidential discussion about your project, or contact Cornelia Camara, Director, Drug Regulatory Affairs EU/US, on +41 (0)22 363 92 06.

Regulatory References