Provided Critical Due Diligence to known Pharmaceutical and Anonymous Organizations regarding Preformulation, Formulation, Analytical Development, and Manufacturing (CMC) issues for:
ULTRAM® tramadol extended release internal formulation development, (Johnson & Johnson Legal), prior to external in licensing
REVLIMID® lenalidomide, polymorph patents for investors (Anonymous)
Fenfluramine, in licensing, CMC for new indication, orphan status (Anonymous)
OTC Softgels, in license, CMC review for Regulatory Submission suitability (Anonymous)
L-Glutamine, in license, CMC for claim of source having superior quality to vitamin store sourced (Anonymous)
Managed CRO outsourced development of 3 Development Projects for Ferring USA over a 16 month period..
ENDOMETRIN® progesterone effervescent vaginal tablets from Pre-clinical support through Phase III CTM/Registration Batches of Drug Product. Authored issues free complete IND CMC Section, and NDA Dosage Form Development History Report.
Human Chorionic Gonadotropin (HCG) sterile injection containing a more highly refined HCG drug substance formulated to comply with current cGMP and ICH/FDA guidelines.
Decapeptide iontophoretic delivery system to initiate ovulation.
> $6 Mil budget each. Developed budgeting models for each novel product development project.
MOXITAG® extended release amoxicillin tablets. Authored of all Analytical Development Department Reports for NDA except for dosage form Stability Report.
Critically Reviewed Analytical Methods Validation Reports for compliance to then current ICH Guidelines and internal SOPs.
Provided critical/feasibility assessments of APIs/NCEs for pulsatile, ER and IR applications; data, projects, presentations, personnel and facilities.
Authored Pharmaceutical Development (J&JPRD), Analytical Development (Ferring, J&J – Merck), and Process Validation (ALZA) Reports for regulatory submissions.
Authored Project Summaries, SOPs and IQ/OQ Protocols for R&D projects and facilities.
PC International
Taught cGMP training course for clinical supplies at several locations.
Critically reviewed preliminary Analytical Methods Validation Report, identified and resolved problems, errors and inconsistencies, and recommended and applied successful solutions. Authored every CMC supportive report document including Methods Development History, Analytical Methods Validation, and Dissolution Method Rationale.
Assignment completed on time in 5 months free of regulatory issues.
Published five articles in technical magazines regarding changes for Expert Witnesses, Patented Technologies, Vendor-client mismatched SOPs, utility of SOPs in the Preformulation Laboratory, and the current state of Preformulation.