Services

Regulatory Strategy Consulting

Attain the right support at any stage of the drug development process and have peace-of-mind with the proven regulatory knowledge needed for success.

Proven pharmaceutical industry consultants with necessary expertise for a successful submission.

MMS strategists provide regulatory intelligence through the collection, analysis, and interpretation of publicly-available and experience-based regulatory information. We work directly with you to create an actionable regulatory strategy to support optimal progress and development.

Phase Specific Strategy

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 and Incentivized Development Strategy

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

Pediatric Disease Development Strategy

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.

Label Development Strategy

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

Strategic Support for Meeting Requests and Packages

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.

Area-of-Expertise Strategy

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 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, including INDs, NDAs, ANDAs, MAAs, NDS, ANDS, DMF, ASMF, IMPD, RTQs, HA meetings, or nonclinical strategy for 505(b)(2) submissions.