Archer Pharmaceuticals Contract Research Services

Custom Synthesis & Contract Services

Concept to Clinic

Targeted API Synthesis
At Archer’s Custom Synthesis Division we assist companies in the synthesis of small molecule APIs by providing fully integrated cGMP manufacturing services that are fast-track, regulatory compliant and cost-effective.
API Manufacturing
Archer’s Custom Synthesis Division is focused on providing services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances. Archer laboratories have been designed specifically to produce bulk Active Pharmaceutical Ingredient suitable for use in preclinical toxicology,large clinical trials and finished products. Our scientists specialize in complex organic synthesis and possess experience in both industrial and academic environments. With an extensive experience and a solid academic background, Archer has a broad range of synthetic organic chemistry capabilities, along with the knowledge of the latest techniques and technologies.

Services Include:
cGMP Manufacture for pre-clinical and clinical APIs • Gram to kilogram synthesis, both cGMP and non-GMP • Manufacture of APIs using protocols supplied by our customers or through synthetic routes designed to suit our customer’s needs • Batch Record creation • Process optimization

Regulatory Support Services
- Quality Assurance
  GMP manufacturing maintains a quality program that meets its specific needs and is consistent with the guidelines provided in the Archer quality plan. Archer Quality Assurance continually monitors these programs to assess their effectiveness. Quality Assurance is also responsible for review, approval, and control of critical processing steps, component release, and documentation in support of GMP manufacturing.
  
  Quality Assurance maintains programs for vendor qualification, and internal and external audits, as well as procedures for responding to client and regulatory agency audits of Archer operations.
- Quality Control
  Extensive testing is required for each stage of the manufacturing process in order to ensure product purity and integrity. Archer Quality Control offers a panel of qualified assays readily available to expedite product and process development. Archer Quality Control can also accommodate specific assays transferred from clients and can develop and qualify these assays in accordance with regulatory requirements. Assays that cannot be accommodated using Archer Quality Control equipment or those that would not be compatible with Archer Quality Control facilities are contracted to qualified outside vendors.