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Drug Development Partner

Parimer is a Drug Substance development company that specializes in the design, development, and manufacturing of new chemical entities to treat human diseases. Our cGMP suites support clients in their development, clinical, and full commercial API efforts with client sizes ranging from 1 employee to clients with 10,000 employees. 

Let our expert, scientist-led teams work with you on the navigation of IND, CMC, ICH, FDA, ISO, and other regulatory challenges from the start, ensuring a seamless journey from development to commercialization.

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Parimer's Breadth of 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

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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. Overall, our team is here to help bring your product to market. ​

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.​

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Product Development Pathway

01

Preclinical Services

Custom design new compounds or polymers with the desired functional group, properties, and behaviors.

02

Clinical Trial Manufacturing

Parimer can develop new Methods, Batch records, and reactor train assembly's to support cGMP manufacturing in our ISO cleanrooms.

03

CMC Regulatory Activites

After early-stage clinical actives, Parimer can support the CMC activities of the client, including stability studies, accelerated stability studies, batch records and other module 3 activities.  

04

FDA Registration Support

Following ICH FDA guidance documents, Parimer supports our clients in their process validation, method validation, forced degradation, fate of impurity and other registration batch activities. 

05

Private Label  Commerical Manufacturing

Once a product is on the open market, Parimer may serve as the contract manufacturer at the client's discretion.

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