End‑to‑end consulting for development, quality, compliance and talent
Drug Product Formulation and Process Development for all global markets. A partner for the full product development lifecycle. We offer in‑depth analysis of platform technologies that provide intellectual property opportunities, a strong basket of products, clinical efficiency/patient compliance, and competitive edge. We help customers take decisions based on rigorous evaluation of proposals and ideas by our team. We take the complexity out of hiring with clear, proactive, and tailored recruitment strategies that actually work—whether you are scaling a team, replacing key talent, or entering a new market. We provide strategy, execution, and ongoing support for virtually any regulatory, compliance, or quality need, and we offer a comprehensive array of services for the disposal, acquisition, and evaluation of pharma plant and R&D equipment and lab instruments. BACHwell specializes in QbD, DoE, PAT, QRM, SPC, and enhancing cost, quality, efficiency and process scale‑up (API).
Stable and effective drug formulations with customized solutions.
Specialized staffing for pharma roles.
Preowned processing & packaging machinery, refurbished lab instruments, servicing the Pharmaceutical, Cosmetic, Nutraceutical, Nutritional Supplement, Food, and Packaging sectors.
Facility design, capacity planning, equipment selection, cGMP compliance, validation, contamination control, gowning, EHS, airflow, water purification, etc. Separate expert teams for Tablets, Capsules, Injectables, Ophthalmic, Liquid Orals, Semi-Solids.
Quality Systems Design, Data Integrity, Validation & Qualification, Risk Management, Supplier Assessments, Authority Response, Audits, Post-Market Surveillance, etc.
Non-compliance comes with a high cost. We provide sustainable processes and rapid response. Health Authority Response, FDA/EMA Support, Rapid Inspections, Remediation, Project Management, Inspection Readiness, Training, SME Support, Post-Inspection Analysis.
CTD/DMF, submissions and agency liaison. Preparation of DMF, Critical Review of Dossiers, Outsourcing Support, Strategic Pharma Regulatory Filing.
Company registration and TS‑iPASS guidance.
Flexible cost-effective solutions from preclinical to clinical. Custom synthesis (small molecules, peptides, nucleotides, steroids). Drug Discovery Services, Structure-based design, Scaffold synthesis, Process Development, Tech Transfer to plant scale-up.
QbD, DoE, PAT, QRM and more. Scale-up (Formulation): Transition lab to pilot/commercial plant scale. In Vivo In Vitro Correlation (IVIVC): USP–NF <1088>, dissolution testing, BA/BE design, BCS categorization, correlation levels, IVIVC application.
