BDR Life Sciences LLC

Consultant and advisor to regulated life sciences, pharmaceutical, biotechnology and medical device companies specializing in Product Development, Tech Operations and Quality. Includes project management, CMC, manufacturing, QA, QC, supply chain, logistics. Select, qualify, and perform tech transfers to CDMOs, CMOs, CTLs, CPOs, 3PLs for clinical and commercial phases. Therapeutic Areas: CNS/neuroscience, rare disease, ophthalmology, endocrinology, oncology, infectious disease Modalities: Biologics: monoclonal antibodies, proteins, stem cells, viruses, antibody drug conjugates, radioimmunotherapeutics. Small Molecules: oral solids and liquids, peptides, oligonucleotides, ASOs. High potency and controlled substances. Formulations: lyophilized, spray dried powders, high viscosity, aqueous, non-aqueous formulations. Combination Products: aseptically manufactured injectables and device constituents including prefilled syringes, autoinjectors, pen injectors, electro-mechanical drug delivery devices, custom syringes, nasal sprays, ophthalmic dropper bottles, intravitreal PFS, radiolabeled mAb for diagnostic imaging. Sourcing, supplier audits and selection. Tech Transfers for Drug Substance (APIs), Drug Products, Finished Products; device constituents, assembly, labeling, packaging, analytical & microbiology labs, validation, 3PL, GMP storage, GDP logistics. Frozen, cold, CRT chain, DEA controls. Facility design, construction, qualifications, cGMP operations. Manufacturing and Quality Assurance documentation. QbD integration, process development, optimization, CAPEX procurement, equipment design, FAT, SAT, qualifications, implementation, scale-up, validations and PPQ. US, Canada, Europe, ROW GCP clinical trials, regulatory approvals, product launches, commercialization. Drafting and reviewing regulatory CMC documents. Quality Management System, ERP implementations, data reviews, investigations, CAPAs, Lean, Six Sigma projects, BD diligence, M&A and partner alliance.