Global Regulatory Affairs CMC Consulting Services

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Summit Regulatory CMC, LLC can define the Regulatory CMC pathway that is unique to your product and company objectives.  In this partnership, we can support your company with Regulatory CMC strategy, leadership, and quality module technical writing.  Below are a few of the comprehensive services offered, with experience in a variety of therapeutic areas, dosage forms, and regulatory regions.  We have experience with the traditional drug development 505(b)(1) NDA pathway, the compressed 505(b)(2) NDA pathway, as well as the abbreviated 505(j) ANDA pathway.

Submissions

Author, review, and manage global regulatory submissions and ensure compliance with regulations and standards of global health authorities.

• NDA, ANDA / MAA
• IND / IMPD
• DMF / ASMF
• Post-Approval Changes and Life Cycle Management

Health Authority Meetings

Provide support to ensure appropriate and timely interaction with global Health Authorities, including pre-submission and scientific advice meetings.  Development of the questions and associated briefing package, scenario planning with internal stakeholders, and leading the Health Authority meeting.

Health Authority Information Requests

Support information requests and queries to avoid delays and further requests.  Triage of the initial query, review of applicable regulatory and/or technical documentation, strategic preparation of the response with appropriate scientific justification.

Due Diligence and Gap Analysis

Identification and review of Regulatory CMC risks, mitigation strategies, and action plans  to minimize future delays, deficiencies, and rejections by global Health Authorities.  Review at various product development stages is a critical activity for existing assets as well as future potential assets, prior to registration and throughout life cycle management.

• Cardiovascular/metabolic diseases
• Dermatology
• Respiratory
• Urology
• Gastrointestinal
• Autoimmune diseases
• Rare diseases
• Pain treatments

• Oral inhalation (including combination products)
• Oral solid
• Topical
• Parenteral
• Transdermal

• United States
• Europe (including UK)
• Canada
• Japan
• Australia