We Offer the Following Specific Services:

• Contract QP for IMP's.

• Applications for EU scientific advice and US Pre-IND meetings.

• Assessment of scientific documentation.

• Assessment of critical path development for Investigational Medicinal Products.

• Clinical Trial Applications.

• Developmental Plans.

• Development of CMC packages.

• Development of Non-clinical and Toxicology packages.

• Drug Master Files.

• Ethics Committee Submissions.

• Investigational New Drug Applications.

• Orphan Drug Designation Applications.

• Regulatory Strategy.

• Scientific and Regulatory due diligence.

• Searches for contract manufacturer’s and contract research organisations.

• Support for development of quality systems, audits and pre-inspection preparation.

• Target Product Profiles.