Our philosophy of getting things done
"They don't ask the most important question: How good is this person at getting things done? In our experience, there's very little correlation between those who talk a good game and those who get things done come hell or high water. Too often the second kind are given short shrift. But if you want to build a company that has excellent discipline of execution, you have to select the doer."
		Bossidy L, Charan R, Burck C. Execution: the discipline of getting things done. 1st ed. New York: Crown Business; 2002.
	Updated August 2008
			CMC conversion from Part II to Module 3 CTD for oral tablets and dual-chamber syringe dosage forms.
			Nonclinical and clinical conversion to Modules 2, 4, and 5 CTD for an oncology indication.
			Data analyses from an NDA to an MAA for hypercholesterolemia via Decentralized Procedure in the EU.
			Evaluation of potential Reference Member States (RMS) for a Decentralized Procedure in the EU.
			Assessment of the need for a Pediatric Investigation Plan (PIP).
			Clinical study exploration in Mexico and Brazil for an Alzheimer's Disease indication and an assessment and a regulatory strategy for drug registration in Mexico and Brazil.
			Regulatory intelligence information for an herbal medicinal product for the EU.
			Regulatory information and plan for registration in the EU of a fixed combination product for a neurology indication.
			Advisor for a clinical trial application in Canada.
			Regulatory strategy for an EU clinical trial application for an extended release oral formulation for an anticonvulsant.
			Literature search and summary for an FDA IND for a new neurology indication.
			Manufacturing site change strategy of a drug substance for the FDA.
			Literature search and summary for a new neurology indication for an FDA IND.
			Clarification of questions for a Phase Ib clinical study of a novel compound in South Africa.
			Regulatory audit of a CRO.
			Peer review of CTD Modules 2.2 Introduction, 2.5 Clinical Overview, 2.7 Clinical Summary, and a package insert for an oral diabetic drug product for submission to the FDA.
			Preparation of an NDA clinical Supplement for an antiviral oral drug product.
			Peer reviewed 2 manuscripts (antibiotic review & neurological therapy meta-analysis) for a MEDLINE indexed medical journal.
	Past Projects
			Researched access to data for generic products through EU FOI channels.
			Prepared a regulatory strategy for an EU registration of an asthma drug product.
			Provided assessment of a non-Investigational Medicine Product (non-IMP) for a clinical trial in the EU.
			Researched and compiled clinical trial requirements for Argentina, Brazil, Chile, Mexico, Peru, and US Virgin Islands.
			Authored responses to a US FDA Cellular Therapy letter.
			Assessed acceptable limits of a residual solvent for registration in the EU.
			Prepared a gap analysis and authored CTD Module 3 for a drug substance, injection, and tablet formulations for registration with the US FDA.
			Wrote the conversation to CTD format Module 3 for a drug substance and an injection formulation.
			Advised on the conduct of clinical trial procedures in Mexico.
			Drafted a literature summary in support of an IND.
			Regulatory affairs audit of a 3rd party supplier.
			Prepared a manufacturing site change strategy for a UK-based drug substance supplier in line with US FDA requirements.
			Provided input into an FDA IND submission for a topical corticosteroid.
			Identified labeling requirements in the EU focusing on UK, France, Italy, and Spain.
			Advised on orphan registration procedures in the EU.
			Authored CMC sections in CTD format for a drug substance, tablet formulations, and sterile injectable drug products.
			Prepared a template of regulatory requirements for clinical trials in the EU, Switzerland, Australia, Russia, Singapore, Argentina, Chile, Costa Rica, Mexico, and South Africa.
			Authored Clinical Trials Applications (CTA) for Germany and the Netherlands including a full IMPD and an application form.
			Prepared a regulatory strategy for a new topical product for the FDA.
			In a project management capacity, worked through the requirements for Pharmacovigilance Planning (ICH E2E guidance) and a Risk Management Plan (RMP) in the EU and the FDA RiskMAP to ensure adherence to the guidelines.
			Reviewed and advised on the preparation of CTD Modules 2.3 and 3 for a combination product for submission to the FDA.
			Offered input and advice on the orphan designation requirements and procedures in the EU.
			Reformatted CMC sections from Part II to CTD Modules 2.3 and 3 for an antiviral product.
			Selected the best option for success and prepared responses for a protocol amendment to the FDA.
			Involved in preparing a regulatory plan for market re-entry of an FDA regulated product.
			Authored a Nonclinical Overview and Written and Tabulated Summary for an NSAID product.
			Conducted regulatory due diligence for a Canadian company.
			Carried out regulatory research for submission plans to the FDA for a new drug substance salt form.
			Prepared gap assessments against current guidelines for a new filing from old dossiers.
			Presented a tutorial for Plant Master File (PMF) requirements in Australia, Canada, UK, Israel, South Africa, and Taiwan.
			Assisted in obtaining & translating SPCs for EU established products.
			Prepared and submitted Orphan designation applications for oncology & endocrinology indications.
			Assimilated regulatory plans and strategies to assist a clinical team in initiating clinical trails in the EU.
			Involved with a drug development team in providing regulatory guidance for a NCE.
			Prepared a DMF in CTD format for Australia, Canada, EU, and the US.
			Prepared Preclinical (Part III) and Clinical (Part IV) documents that included literature references and in-house studies for EU accession dossiers.
			Assisted and advised on the conduct of clinical trials in Latin America.
			Provided intelligence information on EU expansion of multinational companies.
			Provided 6 on-site tutorials (3 hours each) for a Regulatory Affairs department on Chemistry/Pharmacy Part II and compared this with the CTD Module 3 and FDA CMC section.
			Involved in clinical trial requirements and initiation in Latin America primarily Argentina, Brazil, Colombia, Chile, Costa Rica, and Mexico.
			Advised a European company on a generic drug submission to the FDA.
			Investigated and determined the US FDA registration route for a new dosage form of an established compound.
			Reviewed the clinical trial requirements for initiating Phase 1 studies in Mexico and South Africa, and considered the implications of the forthcoming EU clinical trials directive.
			Assisted in planning, writing, and reviewing the CMC section of a US NDA.
			Consulted on the implications of scale-up issues and alternative supplier pertaining to a US NDA registration.
			Managed and prepared BSE/TSE variations.
			Prepared a regulatory plan for initiating multinational clinical trial applications for Belgium, Germany, Italy, The Netherlands, Sweden, Switzerland, and the UK.
			Prepared and submitted 3 manuscripts for publication in peer-reviewed nephrology journals (all 3 were published).
			Prepared preclinical tabular formats and a preclinical written summary for 2 HIV/AIDS drug products for EU centralized marketing applications.
			Successfully prepared a CTX for a new chemical entity oncolytic for the UK.
			Prepared a Clinical Written Summary for a biologic.
			Peer reviewed a manuscript on the nephrotoxicity and efficacy of lipid-based amphotericin B formulations for a MEDLINE indexed medical journal.
			Authored Part II and Chemistry/Pharmacy Expert Report Formats for an antibacterial agent for Mutual Recognition Procedure in the EU.