Regulatory Affairs

We can assist with your regulatory strategy and execution at every stage of development. Because of our disease-based approach, we work closely in collaboration with nonprofit advocacy organizations who themselves have direct access to the FDA. This also means we can help you at any stage by working through the most trusted channels. Whether you are forming your early-stage pre-clinical regulatory strategy or later at the commercial stage when products are launching a product, Massnex can help.

Our unique value proposition helps our clients partner with disease communities during early-stage strategic planning, gaining actionable insights they would never have discovered. We will communicate your product’s medical benefits and efficacy while attending conferences and other health authority meetings to represent your company. Our approach facilitates the approval of your product because we work in collaboration with the communities you serve. The relationships that we will help you form with the most trusted advocacy partners in your condition are invaluable for getting the product approved and managing patient and medical affairs processes at the post-approval stage while monitoring product utilization and market access.

Whether you are a pharmaceutical, biotechnology, and Medtech, Massnex’s regulatory team will help you overcome critical regulatory hurdles. Massnex will provide you with an unsurpassed level of client support while conducting critical regulatory tasks such as:

+ Development and execution of your regulatory pathway strategy; we perform gap assessments and readiness assessments for the existing program, develop integrated development plans and regulatory roadmaps, and design and implement particular designation strategies
+ Assistance with regulatory applications; prepare and submit applications for special designations such as orphan, fast track, breakthrough, and rare pediatric disease
+ Managing marketing applications (NDAs, BLAs, PMAs, 510(k)s)
+ Act as client regulatory representative with the FDA
+ Tactical support for existing strategies, including preparation for meetings, presentations, and material production management
+ Support for companies and investors conducting regulatory due diligence; assessment of medical need and feasibility of the proposed development strategy, including the regulatory and clinical aspects



+1 (857) 891-2909


Mailing Address

57 Broadlawn Park #7

Chestnut Hill, MA 02467, USA