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Expert Services

Case Studies

Product Development and Regulatory Affairs

Clinical and Manufacturing Excellence

GxP Compliance and Risk Management

Application of Nonclinical Expertise leads to Timely Biotechnology Product Authorization

Applying Regulatory and Technical Expertise to Develop and Clear a Timely 510K

Best Regulatory Path to Rapid IND Study Start

Biologics Product Expansion Into the US Market

E-CTD Submission: First in Europe

Innovative CNS Trial Design With Minimal Patient Numbers

NDA and GMP Regulatory Advice Leading to Drug Approval

Obtain FDA Approval with a Single Pivotal Trial

Pre-NDA Meeting for EU CTD-based NDA of Biologic

Reduced Cost of Clinical Pharmacology Trial in Diabetes

Reduced Time to Study Start: Therapeutic Use of Phage

Successful BLA Submissions: Monocolonal Antibody