Whether you are an start-up company building a Quality program or a mature company that needs remediation assistance, we can help. Our seasoned and experienced staff have started programs from a clean slate as well as remediated existing programs that have been found non-compliant with statutory requirements. Our consulting services include but are not limited to:
Corporate Compliance Strategy Development, Implementation, and Resourcing
Building Compliant Quality Management Systems
Remediation of Compliance Issues (483, Warning Letter, Consent Decree & Litigation Support etc)
Due Diligence & Inspections readiness per USFDA requirements
Support development and manufacturing of all dosage forms
Regulatory Strategy and Submissions ( DMF, ANDA, IND, PMA 510k etc)
Technical Consulting (e.g. Sterile, Formulation, API, Bulk Drugs, Excipients etc. Facilities)
Our President Steven Lane has 25+ years pharmaceutical industry experience in progressing levels of responsibility and authority across all dosage forms and scientific platforms. As a Johns Hopkins trained scientist and lecturer, he has a unique scientific and regulatory compliance perspective and a proven track record of success in Quality as well as Operations. Mr. Lane leads our team of highly educated and highly trained consultants to ensure client needs are met.
Our International Sales Director, Haresh Jeswani has over 15 years of experience in Strategic Planning, Sales & Marketing, Business Development, Channel Management and Relationship Management in India. Mr Jeswani has demonstrated abilities in expanding market share, brand building, generating new business and researching-targeting potential customers and an innate flair for accepting challenges with entrepreneurship skills as well as achieving desired sales targets.