Your Pathway to Breakthroughs
Parimer designs, develops, and manufactures new chemical entities to treat human disease. Our cGMP suites support startups to global enterprises across clinical and commercial API production.
Scientist-led and regulatory-savvy, we guide you through IND, CMC, ICH, FDA, and ISO challenges.
Ensuring a smooth path to market.
Parimer's Expertise
Regulatory
Parimer's team will happily share the expertise gained by helping dozens of biotechnology clients enter the market
Excipients
Parimer's team is experienced in polymers, polysaccharides, and other monographed excipients
Small Molecules
Parimer is capable of manufacturing chemical compounds for human use under 21 CFR 211
Medical Devices
Liquid Medical Devices including both FDA 510k and DeNovo Registration per 21 CFR 820
What makes Parimer Different?
Parimer is a small, privately held, US owned and operated company.
We are small enough to be nimble and give each client personal executive attention, while large enough to navigate the onerous FDA requirements for API development.
We pride ourselves on being lean and competitive on pricing and will often price match any competitor (provided they are registered with the FDA for API manufacturing in the USA).
We even waive any rights to ownership for intellectual property developed under contract and will often work with startup companies by accepting some degree of equity in exchange for services.
Our vision is to help small business, academia and bio pharma startups cost effectively scale new innovation
Certified Experts
FDA Registered, ISO Accredited, DEA Licensed, cGMP compliant, led by PhD experts with a dedicated regulatory department ensuring highest standards.
Your Project, Our Expertise
Preclinical Services
Custom design new compounds or polymers with the desired functional group, properties, and behaviors.
Clinical Trial Manufacturing
Parimer can develop new Methods, Batch records, and reactor train assembly's to support cGMP manufacturing in our ISO cleanrooms.
FDA Registration Support
Following ICH FDA guidance documents, we our clients in their process validation, method validation, forced degradation, fate of impurity and other registration batch activities.
CMC Regulatory Activities
After early-stage clinical actives, we support the CMC activities of the client, including stability studies, accelerated stability studies, batch records and other module 3 activities.
Private Label Commercial Manufacturing
Once a product is on the open market, Parimer may serve as the contract manufacturer at the client's discretion.