CHEMICAL-SYNTHETIC in North America

CHEMICAL-SYNTHETIC in North America

Parimer designs, develops, and manufactures new chemical entities to treat human disease. Our cGMP suites support startups to global enterprises across clinical...

About the plant

Parimer Scientific is an independent, American-owned, and operated private scientific service laboratory that was started in 2018. Today, Parimer is best classified as a Drug Substance CDMO that supports dozens of clients in their efforts to get new molecules and treatments to those in need. 

Parimer has no shareholders, private equity interests, or other profit-driven parties beyond the chemists and engineers employed in the company´s operations. This organizational structure allows Parimer to remain highly competitive against more corporate and executive-heavy competitors.  

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Certifications

• ISO
• FDA (cGMP)
• NSF

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Activity

• CHEMICAL-SYNTHETIC, Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Excipients manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
• DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL: 1, 2
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V04) Diagnostic agents
• Markets: FDA (USA)

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Batch Size / Reactor

• Small, 1 - 10 L, 10-100 L, 100 - 1,000 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, R&D, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support, Salt screening, Co-crystal screening, Polymorph screening, Crystallization screening, Chiral resolution screening, Milling, Solid form selection, Customized block synthesis, Impurity synthesis