Process Chemistry & Scale-up
Route selection, kilo-lab to pilot scale-up, in-process control strategy, and impurity-fate mapping.
DoEPATQbDMost clients engage Dr. Whitfield through one of six service lines below. Hybrid scopes are common — for example, formulation work paired with IP positioning.
Route selection, kilo-lab to pilot scale-up, in-process control strategy, and impurity-fate mapping.
DoEPATQbDHPLC, UPLC, GC-MS, ICP-MS, dissolution and stability-indicating methods validated to ICH Q2(R2).
ICHUSPLandscape analyses, FTO searches, claim drafting support and prosecution response strategy.
USPTOEPOWIPOModule 3 authoring support for IND, NDA, ANDA and MAA submissions; deficiency-letter responses.
FDAEMAIndependent expert reports, deposition support and trial testimony in chemistry-centric patent litigation.
LitigationDepositionQuarterly portfolio reviews, technical due diligence for M&A, and bespoke executive workshops.
M&AWorkshop30 minutes, no charge. We define the question, success criteria and constraints.
Fixed-fee or retainer proposal within 3 business days, with clear deliverables.
Weekly written progress notes; mid-point review for any engagement > 4 weeks.
Final report, raw data, and a 30-day free follow-up window for clarification questions.
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