QCP\'s Vast Regulatory Capabilities

1. 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.
Our Regulatory Support Services include, but are not limited to:
Ø Regulatory Strategies
Ø Support of Regulatory Submissions
Ø Support of Meeting with Regulatory Agencies
Ø Design & Review of DDMAC Compliant Promotional Material
Ø Due Diligence or Licensing Evaluation Projects
Ø Regulatory Maintenance Support
Ø Responses to Letters from Regulatory Agencies
Ø Regulatory Systems Design and Implementation
Ø Regulatory or Scientific Advisory Groups
Ø Issue Management Support
Additional details regarding these services are located on the back of this flyer.
Copyright © 2010 Quality Compliance Partners, Inc.

2. 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
Quality Compliance Partners, Inc.
5519 Clairemont Mesa Blvd. #290
San Diego, CA 92117
www.qualpartners.com
Copyright © 2010 Quality Compliance Partners, Inc.