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 FDA (fast track, breakthrough/RMAT, priority review, accelerated approval) and EMA (PRIME designation, accelerated assessment, ATMP development) programs 
• Incentivized Development Strategy Consulting: Consulting for development programs of eligible drugs for orphan, pediatric, QIDP, LPAD pathways/designation, and other FDA and EMA programs eligible for incentives 

Includes support for the development of waiver or deferral requests, paediatric 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.

Includes:​

• 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 505B2 or ANDA (FDA) or Hybrid, Variation, or Extension (EMA), ​
• Other post-marketing label updates, 

Includes preliminary communications with health authorities, preparation of meeting questions and rationales, assistance with meeting packages, meeting preparation, interpretation of responses from health authorities, 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 like INDs, NDAs, ANDAs, MAAs, NDS, Abbreviated New Drug Submission (ANDS), DMF, ASMF, IMPD, post-approval submissions (CBE-0, CBE-30, PAS, Annual Report), RTQs, 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, NOAEL determination assessment of impurities or degradants, gap assessment, nonclinical consulting to support the preparation of dossiers like INDs, NDAs, ANDAs, MAAs, NDS, ANDS, DMF, ASMF, IMPD, RTQs, HA meetings, or nonclinical strategy for 505(b)(2) submissions.