Pharmalytical Consulting
Pharmalytical Consulting LLC is a customer-focused consultancy providing project planning, strategic insight, manufacturing, laboratory, and documentation services to facilitate CMC regulatory filings and enhance product development. They specialize in offering pharmaceutical and analytical talent and leadership for resolving issues and meeting timelines, especially where full-time staffing is not justified.
Industries
Nr. of Employees
small (1-50)
Pharmalytical Consulting
San Diego, California, United States, North America
Services
Consulting to develop CMC regulatory strategies and prepare CMC sections for INDs, amendments, annual reports and NDAs.
Development, qualification and validation of analytical methods for APIs and finished products, with documentation and technical reporting.
Design and management of stability programs, data interpretation and preparation of stability documentation.
Vendor screening, due diligence and contract negotiation support for manufacturing and testing service providers.
Technical oversight of contract manufacturing and laboratory testing including process and method transfers, liaison, data review and auditing.
Formulation and method development services for topical, parenteral, oral and sustained-release drug products, including peptides and proteins.
Consulting to develop CMC regulatory strategies and prepare CMC sections for INDs, amendments, annual reports and NDAs.
Development, qualification and validation of analytical methods for APIs and finished products, with documentation and technical reporting.
Design and management of stability programs, data interpretation and preparation of stability documentation.
Vendor screening, due diligence and contract negotiation support for manufacturing and testing service providers.
Technical oversight of contract manufacturing and laboratory testing including process and method transfers, liaison, data review and auditing.
Formulation and method development services for topical, parenteral, oral and sustained-release drug products, including peptides and proteins.
Expertise Areas
- CMC regulatory compliance and submissions
- Analytical development and method validation
- Formulation development (parenteral, topical, oral, sustained release)
- Technology transfer and outsourcing management
Key Technologies
- Analytical method development and validation
- Stability study design and stability testing
- IQ/OQ/PQ equipment and facility commissioning
- Formulation development for parenteral/topical/oral/sustained-release