CATALYST
A Turn-Key Solution for Full API Development and Manufacturing
ChemWerth offers comprehensive API development and manufacturing backed by unmatched expertise in navigating complex regulatory landscapes. We excel at streamlining approval timelines, reducing costs with in-house development work and maximizing long-term value for our partners.
With a network of over 30 trusted development and manufacturing partners, we’ve built an exclusive ecosystem of service providers that ensure you have access to the right resources exactly when you need them. This, coupled with our scale, expertise and industry connections, allows us to deliver unmatched advantages in pricing, quality and speed—offering you leverage that early-stage companies can’t attain on their own.
42+
YEARS
of experience filing API Drug Master File (DMF) submissions, with 500+ successfully filed.
1
REVIEW CYCLE
or less, over 90% of the time when using ChemWerth to file, beating the industry average of 3. We handle DMFs, NDAs and all regulatory submissions from start to finish.Â
30+
FACTORIES
that are all FDA approved and capable of developing your unique API.
WHAT WE OFFER
A longterm partnership that grants you full access to our expert team of 50+ people who deliver strategic and operational support in the fields of Non-Clinical, CMC, Clinical and Regulatory Affairs. Inlcuding the total IP protection that you expect from a U.S. headquartered company.
SERVICE-BASED
 Service-Based is a pay-as-you-go solution ideal for smaller activities required on a rapid timescale.
PROJECT-BASED
Our Project-Based solution is ideal for large activities with a clear scope. We work closely with clients to build a bespoke solution and define a budget accordingly.
PARTIAL FTE
Our Partial Full Time Employee solution that offers a higher degree of integration with a client’s activities, through the allocation of a dedicated expert, for a flexible period.
ADVANTAGES
TO PARTNERING WITH US
- We fill in your knowledge and capability gaps, freeing your time to focus on critical path functions and raising capital for your next milestone.
- Our services help reduce your costs and eliminate the need to hire costly project managers, regulatory consultants, GMP auditors and others who add limited value but significant expense.
- Our deep expertise and experience keep your project on budget and on schedule.
- We create GLP small-scale process validation batches to support required FDA toxicological studies.
- We ensure FDA-required GMP manufacturing and full-scale process validation for clinical trials. As well as seamless transition between suppliers for scale-up.Â
VALUE-ADD SERVICES
PROJECT MANAGEMENT
We can provide all facets of project management, highly customizable to suit your specific program and timelines. This allows you to avoid hiring multiple, expensive project managers or consultants. Services include but are not limited to API process development, required toxicology studies and GMP auditing of API manufacturing.
REGULATORY SUPPORT
We can provide full preparation and submission of Drug Master Files globally. We provide ongoing DMF support well after the original submission, which includes deficiency response, amendments, annual reports and product milestone timelines to bring products to market faster, resulting in larger market share and revenue potential. We have launched 50+ products that hold “first-to-market” status. Â
COMPLIANCE SUPPORT
We significantly reduce the time, cost and risk of selecting capable and qualified CMOs. We have a large selection of FDA-inspected and -approved API manufacturing partners globally and compliance auditors located in China, India and the U.S. who perform routine GMP audits, ensuring a high level of GMP compliance. We also prepare manufacturing partners for FDA audits and attend all regulatory agency inspections.
“The best part about ChemWerth is you don’t have to think about them; you tell them what you need, they make it happen and you get a finished product and approvals.“
– Reid Waldman, CEO, Veradermics