GMP History and Regulatory Support

Since beginning GMP operations in 2000, PharmaCore has completed over 20 different API projects for Phase I clinical studies. We continue to support many of these projects, making supplies for Phase II and Phase III clinical programs. Please contact us to discuss how our proven track record in API production can assist you with your drug discovery projects.

Audits

PharmaCore welcomes on-site audits by customers. We work with new and existing customers to demonstrate compliance of our facilities and systems. In addition, we periodically contract third-party auditors to inspect and evaluate our GMP operations. The results of these audits are available to our customers. Finally, we perform on-site and paper audits of our major GMP supplier of materials and services. Summaries of these audits are available to our customers.

GMP Experience

PharmaCore manufactures APIs to support Phase I and Phase II Clinical Trials, as well as pre-IND Stage and Tox Stage. Recently, PharmaCore has also supported APIs entering into Phase III. We offer production and analytical document to support process validation, stability studies, methods validation/transfer and reference standards.

Documentation

PharmaCore provides documentation support for IND and NDA applications. We provide a detailed technology transfer to support Phase III and commercial production and also generate information for Drug Master Files for each API produced.

Customers are invited to discuss GMP projects and audit the PharmaCore® facilities. If you have particular questions about our regulatory support, please contact Mike Johnson, associate director of regulatory affairs, via email..