Andrew Makin Preclinical Consulting

Andrew Makin Preclinical Consulting is an independent consultancy specializing in the non-clinical safety assessment of new drug candidates. Founded and led by Andrew Makin, a European Registered Toxicologist with over 30 years of industry experience, the firm provides strategic and technical support to biotechnology and pharmaceutical companies. Key services include the design and management of toxicology programs, preparation of regulatory documentation for IND and NDA filings, and expert representation at meetings with health authorities. The consultancy assists clients in navigating the transition from discovery to clinical trials across various therapeutic modalities, including small molecules and advanced biologics. By providing expert oversight of Contract Research Organizations (CROs), the firm ensures high-quality data generation for regulatory submissions.