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 (EU MDR)

Complying with the new European Union Medical Device Regulations (EU MDR) requires an in-depth understanding of what’s changed in the regulation, general safety, and performance requirements. At Treximo, our consultants have implemented EU MDR with other clients, have regulatory expertise, former FDA/MHRA resources, deeply experienced project/program managers, and experts from Pharmaceutical, Biotech, and Medical Device companies. Together, we can help you navigate the EU MDR to arrive at compliance to the new regulation.

In Vitro Diagnostic Medical Device Regulations (IVDR)

There are several significant changes to be expected with the new In Vitro Diagnostic Medical Device Regulations (IVDR), including product scope expansion, rigorous post-market oversight, implementation of unique device identification, and reclassification of in vitro diagnostics according to risk. Our team at Treximo is comprised of experienced IVD experts who will leverage our deep experience with implementing EU MDR along with our strong project management expertise to 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.