REGULATORY SUPPORT SERVICES

QCP, Inc.'s regulatory team 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, Warning Letter, Consent Decree, or a Complete Response Letter,  we can also 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 or day-to-day activities, or on an advisory, as-needed basis.

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

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       IND/CTAs, NDA/MAA, ANDA, 505 (b)(2)s, 510ks,  supplements and Orphan Drug applications

ü       Review of Proposed Submissions

ü       Clinical, CMC and pre-clinical toxicology reviews

ü       Preparation, Review and Assembly of Submissions (paper or electronic)

Ø       Support of Regulatory Agencies Meetings

ü       Support of FDA and EMEA meetings (i.e. pre-meeting preparations and meeting support)

ü       Pre-NDA submission meetings, Advisory Committee Meetings, End of Phase II Meetings, 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       Clinicaltrials.gov submissions

Ø       Responses to Agency Letters

ü       Warning Letters, 483s, Consent Decrees, Complete Response Letters, IND/NDA review responses

ü       Assist in developing response strategies

ü       Assist with remediation plans, if appropriate

ü       Assist in development of response letter to Agency

ü       Support of Agency Meetings

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