Our Services
Extensive industry expertise that understand the business, technology and changing landscape.
Projects
Good Manufacturing Practice (cGMP) and pre-inspection readiness audits
Preparation for Pre-Approval Inspections (PAI)
Development and assessment of bioassay, bio-analytical, and analytical methods
Chemometrics
Establishing Quality Assurance and Quality Control functions
Knowledge and application of ASTM and ISO standards covering both small molecules and biologics
Risk assessment and developing Quality Risk Management Systems; Process Analytical Technology
Quality by Design
Process Validation
Training
Single Use technologies- use, application and registration
Preparation and Review of NDA, ANDA, IND, IDE, DMF, and Prior Approval Supplement (PAS) applications
Reviewing, assessing and addressing of regulatory documents, regulatory compliance managements (483 observations, Warning Letters responses and Consent Decrees)
Development and delivery of pharmaceutical manufacturing excellence
Implementing process change as well as streamlining regulatory change
Facilitating and managing change- process, culture and regulatory
Regulatory compliance remediation: dealing with 483 observations, untitled and warning letters, 3rd party facility and operational oversight
Solution Capabilities
Drug and Process Development
GMP Remediation
Expert Witness Consulting
CMC Strategy and Support
Audits
Inspection Preparation and Support
Continuous Processing
Risk Management
Process Validation
PAT & QbD Implementation
Data Infrastructure
Regulatory
Process Control & Optimization
Industry Expertise
Active Pharmaceutical Ingredients (API)
Small Molecules
Biotechnology Products
International Regulations
Repeatable processes to ensure that the experience with us is predictable and based on a sound methodology.
