The development of new products and the transfer of existing or launch of new products requires thorough planning, strategy establishment and effective project management combined with knowledge of the regulations enforced by US and International Agencies. Any product to be manufactured, marketed and or distributed in a territory must comply with the internal regulations of the country. Registration of the drug as well as compliance to transfer requirements present interesting challenges to globalizing companies.
- Technology Transfer Strategies
- QbD: ICH Q8 Quality by Design
- ICH Q9 Risk Management
- Technology Transfer and Process Changes Filings to Regulatory Agencies: US, International
- New Products Introduction
- New Technology
- Process Development
- Process Characterization
- Manufacturing Process Gap Analysis to up-to-date standards prior transfer to a new facility
- Process Research and Design of Experiments
- Components and Composition
- Site Changes
- Equipment Changes
- Packaging Changes
- Label Changes
- Changes in Batch Size
- Manufacturing Changes
- Changes in components
- CBEs, Annual Reports, Pre-Approval Submissions for NDAs
- PAI Readiness
- PAI Mock-ups
- New Product Lunch Support
- Batch Records Development & Revision
- SOPs Development
- Process Analytical Technologies (PAT) and New Trends
- Risk Based Approach to Technology Transfer
- SUPAC/ BACPAC
- Equivalency Assessment
- Preformulation Services
- Formulation Development