Regulatory Affairs

We specialize in providing executive regulatory consulting services on both a national and international scale. With a quickly changing global regulatory landscape, Treximo consultants draw from their deep-rooted industry backgrounds and FDA knowledge.

Regulatory Strategy Consulting That is Always Reliable

Treximo’s global regulatory consultants share a big passion with our clients: obtain approval of your product and deliver it to the intended patient population as efficiently, safely, and compliantly as possible. Our consultants have extensive expertise across drug, biologic, biosimilar, and medical device products for both pediatric and adult populations.

Our experts are comprised of FDA-experienced experts, industry regulatory leaders, and professionals with local and global regulation expertise. Our offerings range from defining the product development plan, preparing clients for Agency meetings, and providing guidance on the most expedited path to marketing your drug.

CMC Development Services: Expert-Driven and Industry Trusted

Treximo offers expert CMC strategic support to the Pharmaceutical, Biologic, Biosimilar, and Medical Device industries. Our CMC Specialists and Experts deliver strategy, guidance, and execution within a variety of therapeutic areas, product life cycles, and specialized development plans.

European Medical Device Regulations (EUMDR)

Complying with the new European Union Medical Device Regulations (EUMDR) requires an in-depth understanding of what’s changed in classification, safety, and performance requirements. At Treximo, our consultants are former experts from the FDA, and experts from Pharmaceutical, Biotech, and Medical Device companies who’ve made regulation compliance their craft. Together, we can assess all of your current CE marked devices against the new regulations, conduct a gap analysis, and get you approved with proper placement.

In Vitro Diagnostic Medical Device Regulations (IVDR)

There are 11 significant changes to be expected with the new In Vitro Diagnostic Medical Device Regulations (IVDR), including redaction of grandfathering privileges, stronger surveillance, and reclassification of devices based on an assessment of risk. Our team at Treximo is comprised of dedicated compliance experts who will provide the strategies you need to make your transition efficient and precise.

Key Offerings Include

CMC Regulatory Gap Analysis

Regulatory Labeling Consultation

Regulatory Due Diligence

510(k) Submissions

Investigational Device Exemptions (IDE)

Manufacturing and Controls Submissions (CMC)

NonClinical Drug Development Strategy

Pre-IDE Meeting Planning and Package Preparation

FDA Meetings (Pre-IDE, End Of Phase 2, Pre NDA, FDA Advisory Committee Meetings)

Premarket Approval (PMA)

NDA Submissions: 505(b)(1) and 505(b)(2)

Representation and Interactions with all Local and National Agencies

Formulation and Drug Delivery Strategy and Consultation

Chemistry Regulatory Filings

Clinical Evaluation Reports (CER)

We Teach Our Clients How to Avoid Failure by Utilizing Our Industry Expertise.

Expert Strategies

Our consultants come with experience in CMC, Clinical, and Regulatory for biologics, biosimilars, and large and small molecule product development. With their expertise and our breadth of comprehensive resources, we can implement the full insourcing solution, functional team, or hybrid strategy that is most effective for your clinical or nonclinical drug development.

Proactive Solutions

While there are years given to manufacturers to meet compliance regulations, it can be a costly and time-consuming process. By choosing proactive solutions, such as CMC regulatory gap analysis and FDA meeting preparation, you can eliminate unnecessary procedures and reach regulatory approval faster. Our team of former FDA, medical device, and pharmaceutical company associates have the expertise you need to efficiently achieve compliance.