� Regulatory Strategies�� Support of Regulatory Submissions�� Support of Meeting with Regulatory Agencies�� Design & Review of DDMAC Compliant Promotional Material�� Due Diligence or Licensing Evaluation Projects�� Regulatory Maintenance Support�� Responses to Letters from Regulatory Agencies�� Regulatory Systems Design and Implementation�� Regulatory or Scientific Advisory Groups�� Issue Management Support�

Our Regulatory Support Services include, but are not limited to:�

Copyright © 2010 Quality Compliance Partners, Inc.�

Additional details regarding these services are located on the back of this flyer.�

Quality Compliance Partners, Inc.’s (QCP, Inc.) regulatory team’s in-depth experience and knowledge of Global�Regulatory requirements allow us to provide a fully comprehensive package of regulatory services.�

We can assist you with regulatory strategy and advice, assist with submissions, provide regulatory reviews, and�support on-going regulatory compliance for new product initiatives and product life cycle activities. If you find�yourself in need of help in resolving a regulatory problem whether it be responding to the Agency on a 483, Warn-�ing Letter, Consent Decree, or a Complete Response Letter, we can assist you in developing strategies, plans and�responses.�

QCP Inc.’s regulatory professionals are available on a full-time or part-time basis for special projects, day-to-day�activities, or on an advisory, as-needed basis.�

Quality Compliance Partners, Inc.�

5519 Clairemont Mesa Blvd. #290�San Diego, CA 92117�www.qualpartners.com�

Copyright © 2010 Quality Compliance Partners, Inc.�

Ø� Regulatory Strategies�ü� Development of Regulatory Strategies – Corporate or Product Development�ü� Assessment of Existing or Proposed Regulatory Strategies�ü� Development or Review of Life Cycle Management Plans�

Ø� Support of Regulatory Submissions�ü� Preparation, Review and Assembly of Submissions (paper or electronic)�ü� IND/CTAs, NDA/MAA, ANDA, 505 (b)(2)s, 510ks, Supplements and Orphan Drug Applications�ü� Clinical, CMC and Pre-Clinical Toxicology Reviews�

Ø� Support of Meeting with Regulatory Agencies�ü� Support of FDA and EMA meetings (i.e. pre-meeting preparations and meeting support)�ü� Pre-NDA submission meetings, Advisory Committee Meetings, End of Phase II Meetings,� and Pre-IND Meetings�ü� Preparation of Briefing Books�ü� Coordination of Mock/Practice Meetings�ü� Presentation preparations�

Ø� Design & Review of DDMAC Compliant Promotional Material�Ø� Due Diligence or Licensing Evaluation Projects�Ø� Regulatory Maintenance Support�ü� Advice on Product Life Cycle Activities�ü� Annual Filings/On-going filings/Submissions – CBEs, Periodic Reports (Annual/Quarterly),IND� support – 1572’s, Annual Reports, Study Reports�ü� Submissions to Clinicaltrials.gov�

Ø� Responses to Letter from Regulatory Agencies�ü� Warning Letters, 483s, Complete Response Letters, IND/NDA review responses�ü� Assist in developing Consent Decree Action Plans�ü� Assist in developing response strategies�ü� Assist with remediation plans, if appropriate�ü� Assist in development of response letters to Agencies�

Ø� Regulatory Systems Design and Implementation�ü� eCTD Submission Systems or Regulatory Management Systems�

Ø� Regulatory or Scientific Advisory Groups�Ø� Issue Management Support�ü� Preparation and review of plans and strategies to proactively manage Product issues�