Quality Assurance

White-Salters Consulting can help ensure quality is built into your products by partnering with your team to provide the following support:

  • GLP/GMP/GCP Strategic Advice
  • SOP Development
  • Auditing – Vendors and Internal Systems
  • Review of Nonclinical and Clinical Protocols and Final Reports
  • Batch Records, Stability Data, and Validation Documentation Review and Approval
  • PAI Readiness Training

Regulatory Affairs

Let us partner with you to provide strategic and operational regulatory support for your drug development program in the areas of:

  • Regulatory Strategy Development
  • Submission Support
  • Type A, B and C Meeting Preparation/Management
  • Risk Management (RMP/REMS)
  • Orphan Drug Designation Assistance
  • Medical/Technical Writing

GXP Training

At White-Salters Consulting, we recognize that keeping staff appropriately trained and up-to-date with regulations at all times is challenging, especially when industry guidelines are evolving and changing constantly. As a consequence of experiencing difficulty with maintaining qualified staff, companies are often found to be noncompliant following an audit. We can help!

A Novel Approach

In a field largely driven by staunch regulatory procedures, management compliance, and clinical data, White-Salters Consulting takes a refreshingly personable and creative approach to partnering with organizations in need of sophisticated solutions complemented by real-world advice from experienced professionals who understand each nuance of the industry from top to bottom.

Why is the personable approach an important aspect of our relationships with our clients? Because we value partnerships that are based on trust and a collaborative dynamic that nurtures the best problem-solving practices designed to address complex developmental issues. In short, we integrate into your team to work with key staff members and carefully assess any issues that could affect your path to receiving market authorization.

Our Consultants

White-Salters Consulting employs forward-thinking professionals with proven expertise in all areas of the drug/device development process. Our team is adept at creating the flexible and tailor-made solutions our clients need to thrive and see their development programs succeed. Our consultants’ experience allows them to meticulously assess your business development strategy in order to identify and address the pitfalls that could derail compliance or your application market product.