Project Advisory Services
Meeting short and long-term needs for specialized consulting and advisory services.
MMS Project Advisory Services supports our clients’ needs across the entire product development lifecycle, from early regulatory strategy consultations to clinical trial and marketing authorization submissions. The MMS Project Advisory Services team supports a broad range of projects from discovery, pre-IND to post approval and helps customers navigate the complexities of the regulatory environment to accelerate their time to market.
MMS services support new chemical entities (NCEs), biologics, biosimilars, well-established substances 505(b)(2) pathway and generic drugs.
Utilizing a network of global locations and expertise in all key markets, MMS is committed to helping our clients design and execute the most efficient product development programs. MMS advisors can consult in multiple areas of focus, including clinical, regulatory strategy, compliance, CMC and nonclinical, providing both short-term and long-term guidance, specialized consulting, and advisory services.
MMS Project Advisory Services is built on our experts’ broad and deep knowledge and extensive understanding of the pharmaceutical and device industries. Below are some of the consulting areas of focus.
Begin with the end
MMS consultants begin with the end in mind, focusing on the ultimate and most important goal – product approval. Our consultants are experienced industry veterans with the knowledge and objectivity to provide independent and valuable program insights.
and integrated data
Specialized Advisory Services
Global Quality Management & Regulatory Compliance
MMS supports client’s global quality and regulatory compliance needs, including developing and conducting compliance audits, quality management systems (QMS), CAPA, gap analyses, vendor and site audits, mock inspections, inspection readiness, clinical trial disclosures, preparing responses to FDA requests for information, supporting clients in FDA interactions including refusal to file, reanalysis, resubmission strategies and clean-up projects.
There may be a very specific issue or challenge that you or your team need assistance with. MMS consultants can help. MMS’ extensive network of advisors includes consultants with expertise to help with issue identification, root cause analysis and issue resolution. MMS consultants will help your teams address the specific challenge head on with innovative and experience-based advice.
MMS consultants help evaluate assets for potential acquisition or for portfolio prioritization. Industry experts with extensive drug development experience can assess risks including regulatory, safety and other potential development obstacles.
Clinical Development Planning
MMS consultants can create or review clinical development plans, the target product profile, safety management plans (DSUR/PSUR), statistical analysis plans, interim analysis plans, data management plans, study data standardization plans, regulatory submission plans, diversity plans and risk management plans.
Clinical Study Design and Execution
MMS consultants assist with creating established and novel clinical trial designs that improve the probability of clinical and commercial success with the end goal of approval in mind. This includes decentralized clinical trials (DCT) or hybrid clinical trials. We can also provide guidance on inclusion, exclusion criteria and proactively address patient safety concerns.
Safety and Benefit Risk Evaluation
MMS consultants assess and optimize integrated safety and benefit risk management. They can also assist with Risk Evaluation and Mitigation Strategy (REMS). MMS provides safety and clinical consulting, medical review, medical monitoring and pharmacovigilance services.
Product Life Cycle Management
MMS helps pharmaceutical companies consider portfolio and life cycle product management including additional indications, label expansion strategies to extend or add value to their product portfolio. This includes use of real world evidence (RWE) and real world data (RWD)
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