About Irisys, llc
Irisys, LLC: Your Trusted Partner in Drug R&D, GMP Manufacturing, and Regulatory Compliance
Are you looking for a reliable partner to help you bring your innovative biopharmaceutical products to market? Look no further than Irisys, LLC – a San Diego-based Contract Development and Manufacturing Organization (CDMO) that specializes in drug research and development (R&D), Good Manufacturing Practice (GMP) manufacturing, regulatory compliance, and strategic partnerships.
With over 20 years of experience in the pharmaceutical industry, Irisys has established itself as a trusted partner for biopharma companies of all sizes. Whether you are a startup with an exciting new drug candidate or an established company seeking to expand your product portfolio, Irisys can provide the expertise and resources you need to succeed.
Drug R&D Services
At Irisys, we understand that successful drug development requires more than just scientific expertise – it also requires strategic planning and efficient execution. That's why we offer a comprehensive suite of R&D services designed to help our clients navigate the complex drug development process from start to finish.
Our R&D services include:
- Preclinical studies: We can conduct in vitro and in vivo studies to evaluate the safety and efficacy of your drug candidate.
- Formulation development: We can develop optimized formulations for oral solid dosage forms (OSD), injectables, topical creams/ointments/gels/solutions/suspensions/emulsions/foams/sprays etc., inhalation products etc.
- Analytical method development & validation: We have extensive experience developing analytical methods for various types of drugs including small molecules & peptides/proteins/biologics/vaccines etc.
- Clinical trial support: We can provide clinical trial material manufacturing & packaging services as well as clinical supply chain management support.
- Regulatory affairs consulting: Our team has deep knowledge about global regulatory requirements including FDA/EMA/Health Canada/TGA/MHRA/NMPA etc. We can assist with IND/NDA/BLA submissions as well as post-marketing activities such as CMC changes/variations/renewals etc.
GMP Manufacturing Services
Once your drug candidate has successfully completed preclinical testing and entered clinical trials phase I-IIa/b/c or beyond , it's time to scale up production for larger-scale clinical trials or commercialization. At this stage , GMP manufacturing is critical . As an experienced CDMO , Irisys offers state-of-the-art GMP manufacturing facilities that meet global regulatory standards .
Our GMP manufacturing capabilities include:
- OSDs : Tablets/Capsules/Powders
- Injectables : Liquid/Semi-solid/Lyophilized
- Topicals : Creams/Ointments/Gels/Solutions/Suspensions/Emulsions/Foams/Sprays
- Inhalation Products : MDIs/DPIs/Nebulizers
We also offer customized packaging solutions tailored specifically to each client's needs .
Regulatory Compliance Services
Navigating the complex web of global regulations governing pharmaceutical products is no easy task . At Irisys , we have extensive experience working with regulatory agencies around the world . Our team includes experts who have worked at FDA / EMA / Health Canada / TGA / MHRA / NMPA etc. This allows us not only understand but anticipate potential issues during product development cycle .
Our regulatory compliance services include :
1) Gap analysis against applicable regulations
2) Preparation/submission/review/approval of IND/NDA/BLA submissions
3) Preparation/submission/review/approval of CMC changes/variations/renewals
4) Establishment registration/listing
5) DMF preparation/submission
Strategic Partnerships
At Irisys , we believe that collaboration is key success . That's why we work closely with our clients throughout every stage of their product lifecycle - from early-stage research through commercialization - providing guidance on strategy formulation based on our deep understanding about market trends/regulations/scientific advancements/patient needs/etc.
We also collaborate with other service providers such as contract research organizations (CROs), contract testing laboratories (CTLs), technology transfer consultants(TTCs), patent attorneys/law firms/IP consultants/etc., which enables us deliver integrated solutions tailored specifically each client’s unique needs .
Contact IRISYS Today!
If you're looking for a reliable partner who can help take your innovative biopharmaceutical products from concept through commercialization while ensuring quality/compliance/cost-effectiveness/time-to-market advantages then look no further than IRISYS! Contact us today!