Pharma

Auditing & Regulatory Affairs Compliance

Verification that Due Diligence has been applied.

• Including pharma, medical device, and food GMP environments as described by Title 21 CFR § 111, 117, 211, 820 for
  manufacturing, storage, and laboratory operations.
• Priority response and support for FDA citations, warning letters and Form 483. Management system Gap assessment and agency CAPA response.
• Experienced CDMO management including supplier qualification, surveillance auditing, and for-cause auditing. Management of custom starting material manufacturing, advanced intermediates, and APIs.
• Equity Due Diligence. Assessment of management control systems and elucidation of potential risks, opportunities, and liabilities.

Business Strategy & Product Development

Qualified and experienced support for drug development and medical device manufacturing.

• Quality Management System implementation and gap assessment.
• Process validation for API batch synthesis, continuous commercial operation process performance qualification and validation of medical device drug substance combination products.
• Program and process development utilizing principles of risk management, design qualification, FMEA, and process validation to ‘get it right the first Driving outcomes through continuous process improvement.
• Experienced design input for new manufacturing facilities for drug substance manufacturing, medical device assembly, and laboratory support operations.
• Scoping, planning, and project management of requirements for Computer System Validation in regulated environments including integration of multiple LIMS and QMS platforms.

Translational Chemistry

Consulting for business initiatives spanning the med-chem & Intellectual Property phases through scale-up and IND supporting clinical trial material manufacturing and commercial product development.

• Characterizing and defining appropriate cGMP Chemistry & Manufacturing Controls based on chemical, biological, and physical hazards.
• Phase appropriate regulatory compliance. Understanding and defining the controls required at each stage of product development from design through commercial product manufacturing.
• Design and optimization of batch and continuous process manufacturing operations. Scale up of synthesis from bench to kilo scale, and from kilo scale to pilot/commercial scale operations. Equipment qualification and process validation at each development stage.

Analytical Chemistry

20 years experience supporting On Time, On Budget, On Specification, and On Yield operations.

• Analytical work review and method development for general wet chemistry, compendial methods, technology transfer, spectroscopy (UV, IR, NIR), and GC/HPLC chromatography.
• Support for drug substance characterization and elucidation of unknown process impurities.
• Analytical method validation, protocol development, and inter-laboratory technology transfers & method validations. Method development to support new chemical entities.
• Industrial cleaning assessments, sanitation SOPs, and program realization. Implementation of control schemes, analytical cleaning method validation, residue carry-over specification development and support for qualification of ISO classified environments.
• Review of analytical methods and stability programs for compliance with ICH Q2A(R1) including protocol development, assignment of shelf-life based on stability data, and verification of stability indicating methodology.
• LIMS and eQMS assessment, implementation, and computer system validation (CSV). Scoping of systems which require CSV and the magnitude of data fidelity required for ancillary support systems.