Generics
Our Expertise in Generics Development
As a leading generics CRO, Accelsiors empowers your generics development with unmatched expertise, strategic insight, and global reach. We specialize in navigating the complexities of generics development, delivering tailored 505(b)(2) CRO services, complex generics development, and ANDA bioequivalence testing to accelerate time-to-market, ensure FDA compliance, and maximize commercial success. Partner with us to transform your generics program into a market leader.
Accelsiors excels in three key areas of generics development, combining scientific precision with regulatory and market-driven strategies:
- 505(b)(2) CRO Services: Our 505(b)(2) development expertise streamlines your path to approval by leveraging existing data. We design precise bridging studies (PK, BA/BE, food-effect) and craft FDA-aligned regulatory strategies through pre-IND meetings, securing exclusivity and differentiation for new formulations, indications, or delivery systems.
- Complex Generics Development: We specialize in complex generics, including inhalation products, transdermal systems, and modified-release formulations. Our deep knowledge of bioequivalence challenges and specialized delivery systems ensures your product meets stringent FDA standards and stands out in competitive markets.
- ANDA Bioequivalence Testing: We deliver robust bioequivalence studies for ANDAs under the 505(j) pathway. Our optimized study designs and global clinical network provide high-quality data to demonstrate equivalence to reference listed drugs, accelerating your generic approval.
Why Choose Accelsiors for Generics?
Our integrated generics CRO services address the unique challenges of generics development with efficiency and precision:
- Seamless Regulatory Navigation: We guide you through FDA requirements, ensuring compliance and minimizing redundant studies.
- Precision Clinical Studies: Our expertise in PK/BA/BE studies delivers regulatory-ready data, optimized for cost and speed.
- CMC Strategic Consulting: We provide expert guidance on formulation, stability, and regulatory requirements, aligning your CMC strategy with FDA standards and collaborating with your CMO for compliant production.
- Market-Driven Innovation: We position your product for success with scientific, medical, and commercial assessments.
- Global Reach: Our worldwide clinical network accelerates recruitment and delivers high-quality data.
With decades of experience, Accelsiors is your trusted generics CRO for 505(b)(2) development, complex generics, and ANDA bioequivalence testing. Our end-to-end services ensure your program is efficient, compliant, and market-ready.
Accelsiors’ experts have built numerous biosimilar trial designs and managed clinical studies in various therapeutic indications.
We have conducted the following:
- over 30 biosimilar studies, from first-in-human Phase I clinical trials to complex Phase III registration studies
- Ten biosimilars and several “bio better” development programs from simple peptides to complex monoclonal antibodies, including the first modern long-acting rhGH
- Several successful out-licensing and marketing authorizations of biosimilar products both in Europe, North America, and in other regions around the world