IDRAC Database: Consultants - ASEAN

Omnicare Clinical Research
Tel: +49 6196 5228 350
Fax: +49 6196 5228 155

Web site: www.OmnicareCR.com
E-mail: Martine.Dehlinger-Kremer@OmnicareCR.com

Right From the Start, Right to the End
Are you looking for reliable regulatory consulting that works diligently for you? At Omnicare Clinical Research, our Regulatory Affairs professionals are dedicated to ensuring the successful and timely submission of your application. We work closely with you, from project initiation to completion, to determine your specific business needs and to meet your timelines. Our experts can provide the strategic regulatory guidance to:

• Expedite the compilation and submission of your application
• Produce a submission acceptable to local and/or global regulatory authorities
• Facilitate regulatory review to achieve faster study initiation or product approval

The Road to Success
Success speaks for itself. Omnicare Clinical Research has contributed to the successful approval of numerous regional and global investigational and marketing applications without receiving any notifications of clinical hold/objection or refusals to file. To date, these submissions include 58 NDAs/BLAs, 24 MAAs (including CTDs), 124 national filings (including CTDs), 7 Orphan Drug applications and many INDs, CTAs, and CTNs. Our 100% global success rate demonstrates that we have the ability to manage submissions worldwide, the experience to meet timelines and the drive to produce results.

Commitment to Quality
Selecting the right consultant is critical to ensuring the quality and success of your project. At Omnicare Clinical Research, we understand that a properly-prepared submission is critical to the approval process of your application. We meticulously review all submissions for completeness and assemble each submission according to regulatory requirements. Our regulatory track record demonstrates our commitment to quality. When you trust your project to our regulatory experts, you gain the extensive experience and unparalleled success that is the hallmark of Omnicare Clinical Research.

Ready to Deliver
Experience ensures readiness for any challenge. Omnicare Clinical Research has the global regulatory expertise and the knowledge of applicable regulations to oversee submissions to U.S., EU, Japan, Asia-Pacific and Canadian regulatory authorities. Examples of our services include:

• Regional and global product development and registration strategy
• Compliance audits for good clinical/laboratory/manufacturing practices (GXPs)
• Drug import/export
• Implementation of internal change control systems
• Report preparation/publishing/submission
• Clinical trial authorizations (e.g., IND, CTA)
• Marketing authorization dossiers (e.g., NDA, MAA, dossiers in CTD format)
• Creating prescribing information
• Assessing advertising and promotional materials
• Regulatory authority liaison
• Regulatory intelligence/due diligence
• Post submission support (e.g., annual reports, amendments, variations)
• Training seminars