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PharmaCore - Contract Research and GMP Scale-Up

Since 2000, PharmaCore® has performed a variety of chemistry services for leading pharmaceutical and biotechnology companies including: custom organic synthesis; cGMP scale-up; development of novel molecular building blocks; chemical process research and development; and medicinal chemistry services.

Nearly all of PharmaCore's 40+ synthetic chemists have come to us with post-doctorates and / or previous industrial experience. These scientists are adept at devising new synthetic routes for targeting molecules. PharmaCore has a proven track record from synthesis of analogs on a mg scale to the scale-up of lead compounds.

PharmaCore has all the tools necessary to support medicinal chemistry needs, such as advanced analytical instrumentation (NMR, LC-MS, GC-MS, HPLCs with diode array and evaporative light scattering detectors), preparative HPLCs, and literature searching services.

GMP manufacturing and APIs

PharmaCore has developed an outstanding state-of-the-art facility to serve the growing need for GMP clinical material and bulk active pharmaceutical ingredients (APIs) accompanying the rapid pace of drug discovery. The PharmaCore GMP manufacturing facility includes: eight process suites; broad process capability; GMP analytical testing; stability chambers and testing; sample retention; process safety testing; and GMP regulatory support.

Process development is a significant focus in order to ensure a smooth scale-up from small-scale to our GMP process. Our chemists focus on optimizing routes, improving yields and process safety through the course of each project. Process understanding gained from lab-scale synthesis is seamlessly transferred and applied to kilo and pilot scale processes.

Analytical services

At PharmaCore, we understand that dedicated analytical support is as important to our clients as GMP synthesis. Our team has the experience you can rely on to provide the highest quality analytical support for every GMP project. Our expertise in research and compliance will ensure that your project is completed in a professional manner.

We offer a variety of services including: analytical methods development / validation / transfer / improvement; residual solvents methods development / validation; ICH stability studies storage and testing; reference standard qualification; product release/product retain; and raw material testing.

Regulatory support

PharmaCore invites all customers to audit our facilities. We also regularly perform third-party audits. PharmaCore manufactures APIs to support Phase I and Phase II clinical trials, as well as pre-IND and Tox stage. We can also support some APIs entering Phase III.

We provide documentation support for IND and NDA applications. PharmaCore can also provide detailed technology transfer to support process validation, stability studies, methods validation / transfer and reference standards.

PharmaCore, Inc.
Contract Research and GMP Scale-Up
4180 Mendenhall Oaks Parkway
High Point, NC 27265

Tel: (336) 841-5250
Fax: (336) 841-5251
info@pharmacore.com
www.pharmacore.com