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Regulatory Services

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Quality Compliance Partners, Inc's (QCP) regulatory team has in-depth experience and knowledge of regulatory requirements and can provide a range of regulatory services to support your regulatory needs.  

QCP Regulatory Services

QCP's regulatory team can assist you with regulatory strategy and advice, assist with submissions, provide regulatory reviews, and support on-going regulatory operations 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 assist you in developing strategies, plans and responses.

 

QCP's regulatory professionals are available on a full-time or part-time basis for special projects or day-to-day activities.

Our Regulatory Support Services

QCP Regulatory Services

Regulatory Strategies

  • Development of Regulatory Strategies – Corporate or Product Development

  • Assessment of Existing or Proposed Regulatory Strategies

  • Development or Review of Life Cycle Management Plans

   
Support of Regulatory Submissions

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

  • Review of Proposed Submissions

  • Clinical, CMC and pre-clinical toxicology reviews

  • Preparation, Review and Assembly of Submissions

   

Support of Regulatory Agency Meetings

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

  • Pre-NDA submission meetings, Advisory Committee Meetings, End of Phase II Meetings, Pre-IND Meetings

  • Preparation of Briefing Books

  • Coordination of mock/practice meetings

  • Presentation preparations

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QCP Regulatory Services

Design & Review of DDMAC Compliant Promotional Material

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Due Diligence or Licensing Evaluation Projects

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Regulatory Maintenance Support

  • Advice on Product Life Cycle Activities

  • Annual Filings/On-going filings/Submissions – CBEs, Periodic Reports (Annual/Quarterly), IND support – 1572’s, Annual Reports, Study reports

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Responses to Agency Letters

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

  • Assist in developing response strategies

  • Assist with remediation plans, if appropriate

  • Assist in development of response letter to Agency

  • Support of Agency Meetings 

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Regulatory Systems Design and Implementation

  • eCTD Submission Systems or Regulatory Management Systems

  • Regulatory or Scientific Advisory Groups

  • Issue Management Support

  • Preparation and review of plans and strategies to proactively manage product issues

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