Large Molecule Bioanalysis Advice

LMBA helps with the design, qualification and validation of bioanalytical experiments for large molecules to support clinical studies for drug or vaccine development. Experimental data support is of great importance when developing medicines and vaccines. Of course, regulatory bodies place high demands on the quality of bioanalytical experiments that produce the data. After all, these data describe the safety and efficacy of the product. Proper development, qualification and validation of bioanalytical assays form the basis of high quality data. As a medical biologist within the biotech industry, I have extensive and current knowledge and experience with regard to the development of medicines and vaccines. With more than 13 years of experience in bioanalysis, I can assist you in the development of PK, PD, immunogenicity and biomarker assays. We offer the following service: - Advice on setting up, qualifying and validating bioanalytical assays in accordance with the applicable guidelines - Technical Writing and review of regulatory documents such as protocols, experiment plans and reports - Training on experiment qualification and validation according to the most recent guidelines from regulatory authorities such as FDA, EMA and ICH - Assistance with selection of CROs and audits of CROs - Lab training with the help of Virtual Reality (VR)