Thomas A. Walker, PhD and Associates, Inc. offers a variety of services and expertise for pharmaceutical companies of all size with respect to analytical and pharmaceutical chemistry; from discovery to development and commercial. Our analytical chemistry services include: guidance in method development and validation, technical transfer of methodology, equipment and instrument qualification, preformulation, specification setting, stability study evaluation for APIs (Active Pharmaceutical Ingredient) and finished drug products.

We have experience with many different types of molecules including small molecules, long-chain peptides, and oligonucleotides APIs and finished drug products. We maintain a corporate philosophy of offering responsive, high-quality, and timely services that will guide a companies efforts from Pre-IND through Regulatory post-approval supplements and amendments.

We perform technical writing of SOPs (Standard Operating Procedures) for a variety of pharmaceutical development and quality assurance operations as well as the preparation and writing of scientific reports.
Regulatory support is provided for: 1) IND, NDA, ANDA and eCTD submissions, 2) providing guidance from initial compound discovery through regulatory approval, and 3) post-approval supplements and amendments.