Gregory P. Kushla

Jeiven Pharmaceutical Consulting, Inc. (JPC) brings over twenty years of experience to our goal of providing pharmaceutical, biotechnology, medical device and dietary supplement companies with an unparalleled level of service and dedication to ensure the success of their projects. Our clients, which range from the small start-up to the large pharmaceutcial firms, come back to us because they know we will provide them with the highest level of service in combination with the expertise of our skilled consultants. The hallmark of our success has been our outstanding customer satisfaction and client retention. We take pride in providing, above all else, Reliable Guidance to clients of all sizes. Our areas of expertise include: 1) Clinical Trial Materials Project Management 2) Quality Assurance and Compliance 3) Auditing (contractors, suppliers, due diligence audits, mock-PAI audits, general GMP, GLP, GCP audits) 4) Training (GMP, GLP, GCP, DEA) 5) Regulatory Submissions (IND, IDE, CMC, 510(k), PMA, NDA, ANDA, eCTD) 6) Authoring SOPs and Quality Manuals 7)Formulation Development 8) Scale-up, Optimization and Method Transfer 9) Equipment Qualification 10) Analytical Method Development 11) Combination Drug / Device Products 12) Due Diligence Services for Venture Capital Firms 13) Process / Facilities Validation 14) Staffing 15) Comparator Drug Sourcing 16) Organizing the Clinical Supplies Support Group (CSSG) 17) Medical Device and In-vitro Diagnostics