Regulatory Strategy Consulting

• Early Development Strategy Consulting: Consulting on early clinical development from preclinical/first in human to prior to the end of Phase 2
• Clinical/Late-Stage Strategy Consulting: Consulting on clinical development from Phase 2 to Marketing Application
• Establishment/Lifecycle Consulting: Consulting on product launch, maintenance, or further development after product licensing

• Expedited Development Strategy Consulting: Consulting on United States Food and Drug Administration (FDA) (fast track, breakthrough/Regenerative Medicine Advanced Therapy (RMAT), priority review, accelerated approval) and European Medicines Agency (EMA) (priority medicine (PRIME) designation, accelerated assessment, advanced therapy medicinal product (ATMP) development) programs
• Incentivized Development Strategy Consulting: Consulting for development programs of eligible drugs for orphan, pediatric, Qualified Infectious Disease Product Designation (QIDP), Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) pathways/designation, and other FDA and EMA programs eligible for incentives

MMS supports the development of waiver or deferral requests, pediatric investigational plans (PIPs) and pediatric study plans (PSPs), incorporation of agency feedback, and pediatric written requests (PWR) acceptance, amendment, or annotation to support an exclusivity claim.

MMS experts provide trusted label development leadership, including:

• Assessment and evaluation of predecessor labeling
• Discovery questions to contribute to identification of applicable labeling content
• Advising on labeling to support clinical trials
• Early (aspirational) label development
• Label development in support of a marketing authorization (prescription or over‑the‑counter [OTC])
• Label development in support of a 505B2or Abbreviated New Drug Application (ANDA) (FDA) or Hybrid, Variation, or Extension (EMA)
• Other post-marketing label updates

MMS provides preliminary communications with global health authorities, preparation of meeting questions and rationales, assistance with meeting packages, meeting preparation, interpretation of responses from the agency, and follow-up.

Therapeutic Area/Expert Consulting: Includes providing regulatory strategists with therapeutic area-specific expertise or requests for consulting with key opinion leaders or members of the MMS Scientific Advisory Board.

Chemistry and Manufacturing Controls (CMC) Strategy Consulting: Includes Quality by Design (QbD) consulting, CMC consulting to support drug substance (DS), drug product (DP) formulation, development and manufacturing, validation activities pre- and post-approval, gap analysis, and technology transfers. CMC consulting to support the preparation and submission of dossiers, including Investigational New Drugs (INDs), New Drug Applications (NDAs), ANDAs, Marketing Authorisation Applications (MAAs), New Drug Submission (NDS), Abbreviated New Drug Submission (ANDS), drug master file (DMF), Active Substance Master File (ASMF), Investigational Medicinal Product Dossier (IMPD), post-approval submissions (Changes Being Effected – Level 0 [CBE-0], Changes Being Effected – Level 30 [CBE-30], Prior Approval Supplement [PAS], Annual Report), response to questions (RTQs), health authority (HA) meetings, CMC global environmental analyses, and assessment of impurities or degradants, etc.

Nonclinical Strategy Consulting: Includes nonclinical program design, drug discovery development plan, risk and benefit assessment, safety assessment, nonclinical study analysis, no-observed-adverse-effect level (NOAEL) determination assessment of impurities or degradants, gap assessment, nonclinical consulting to support the preparation of dossiers, including INDs, NDAs, ANDAs, MAAs, NDS, ANDS, DMF, ASMF, IMPD, RTQs, HA meetings, or nonclinical strategy for 505(b)(2) submissions.