President

• Mar 2019 - Present

TCG provides quality and regulatory consulting services to the Pharmaceutical, Biologics and Medical Device Industries. Our services Include Auditing, Gap Assessments, Regulatory strategy and submission support, due diligence support and response to FDA enforcement actions including: 483s, Warning Letters, Consent Decrees (permanent injunctions), AIP (Application Integrity Policy), Expert Witness for litigation support, Import Alerts, and Product Seizures. TCG provides quality and regulatory consulting services to the Pharmaceutical, Biologics and Medical Device Industries. Our services Include Auditing, Gap Assessments, Regulatory strategy and submission support, due diligence support and response to FDA enforcement actions including: 483s, Warning Letters, Consent Decrees (permanent injunctions), AIP (Application Integrity Policy), Expert Witness for litigation support, Import Alerts, and Product Seizures.

Vice President, Quality Systems, NSF Health Sciences Pharmaceutical and Biologics

• Dec 2014 - Mar 2019

VP, Quality Systems, NSF Health Sciences Pharmaceutical and Biologics

• Jul 2013 - Mar 2019

President

• Jul 2010 - Jul 2013

Consultant

• Feb 2010 - Jul 2013

Principal Consultant

• Jun 2009 - Jul 2013

U.S. project lead for large-scale multi laboratory sampling and testing effort as part of AIP response to FDA. Formulated sampling plan based on product therapeutic significance, quality and AQL metrics. Coordinated complete testing effort at all U.S. sites. ·Worked with foreign and domestic clients in the pharmaceutical, medical device and biotechnology industries to develop quality assurance and regulatory strategies for compliance with industry regulations. ·Conducted GMP and GLP inspections of facilities and audited ANDA data submitted to the FDA as part of AIP regulatory status. ·Primary area of focus includes ANDA application review sections covering; production and batch records, stability data, validation data and qualification records, supplements, amendments and bioequivalence studies. ·Provided additional oversight and audits over laboratory areas for evaluation and review of quality systems including documentation traceability and training records. ·Made recommendations to client company’s senior management and provided strategy to effectively respond to FDA regulatory actions. ·Formulating responses to FDA in response to sampling and testing plans based on AQL levels for products under AIP review. Show less

Director QC & RD

• Apr 2007 - Apr 2009

A key member of the upper management team responsible for the decision to pursue prospective drug candidates based on product feasibility, market potential and regulatory pathway. Involved in financial activities including preparing financial and operational statements and performing company valuations based on multiples valuation approach of comparable companies model to present to private equity investors. ·Responsible for the preparation of CMC sections, including pharmaceutical development reports and quality overall summary reports, for drug product submissions the FDA via section 505(b) 2 “Paper NDA” applications. ·Generate project timelines and highlight critical path items to ensure timely project execution and completion. ·Oversee the Development of analytical methodology; Validation Protocols and Reports for submission to FDA as part of NDA drug applications. ·Lead Laboratory through several successful audits and inspections. Show less

Director of Research

• Oct 2006 - Apr 2007

Director of Pharmaceutical, Biotechnology and Medical Device Business Unit. ·Lead a group consisting of a Research Manager and a team of researchers to fulfill client needs for Major Pharmaceutical, Biotech and Medical Device companies within the Life sciences space. ·Responsible for the negotiation of pricing and contract structure with clients for research recruitment projects. ·The primary client relationship manager for all research projects in the Life Sciences Business Unit, as the industry expert played a key role in guiding clients into appropriate research avenues for procurement of desired talent and data. ·Maintain client relationships by providing a consistent high level of service and continually communicating with clients before during and after completion of projects to ensure needs are being satisfied. ·Allocate internal resources to ensure constant throughput, efficient workflow, and to ensure timely results for clients. Show less

Laboratory Manager

• Dec 2005 - Oct 2006

Responsible for the management of laboratory functions, processes and personnel. Played vital role in bringing a company under consent decree back in to compliance with cGMP issues and FDA regulations. Developed and implemented internal policies to aid the company with the re-launch of products. Implemented sample stability program and method validation program in order to re-launch products. Develop methodology; Validation Protocols and Reports for submission to FDA as part of audit follow up action. Primary laboratory contact for auditors and inspectors from major clients and regulatory agencies. Lead Laboratory through several successful audits and inspections. Responsible for purchasing, negotiating and coordinating external testing contracts and third party maintenance agreements with external vendors. Key role in product development decisions, with respect to stability enhancement of products and feasibility of products. Show less

Scientist/Group Leader

• 2003 - 2005

Responsible for the management of the analytical activities in preparation for ‘first to file’ ANDA opportunities with multi million dollar revenue potential. Setup the analytical laboratory layout and procured the requisite initial laboratory equipment from vendors. Create and implement policies for handling of Schedule II-V controlled substances in accordance with DEA regulations. Develop HPLC methodology and validate methods as per protocols. Originator of validation protocols, and reports submitted to FDA as part of CMC section in ANDA filings. Coordinate and develop safety procedures in conjunction with requirements from regulatory agencies. Mentor and train new employees on company policies and procedures and analytical methodology. Determine feasibility and cost of product development to facilitate the selection of new drug candidates. Meet with cross functional groups to select final clinical drug candidates by providing stability and release rate information. Show less

Scientist

• 2000 - 2003

Management of the method development process in accordance with FDA and various regulatory agencies. Routinely resolved investigations from the Quality Control group by working in conjunction with technical services group. Method development and validation of stability indicating HPLC methodology for Transdermal drug products. Execute validation protocols and generate validation reports and facilitate method transfers to Quality Control lab. Worked closely with the R&D group to identify final working formulations by generating test results and interpreting data. Facilitated transfer of analytical methods by providing technical assistance and incorporating input from management and analysts into methodology. Show less

Scientist

• Feb 1998 - Dec 2000

Developed procedures and testing guidelines for product formulations in accordance with FDA, USP and ICH guidelines. Trained new chemists and managed Quality Control investigations. Provided drug stability profile on product formulations to select prospective drug candidates Developed and validated HPLC stability indicating testing methodology for clients to meet contractual milestone payments. Developed procedures and testing guidelines for product formulations in accordance with FDA, USP and ICH guidelines. Trained new chemists and managed Quality Control investigations. Provided drug stability profile on product formulations to select prospective drug candidates Developed and validated HPLC stability indicating testing methodology for clients to meet contractual milestone payments.

Chemist/Team Leader

• Jan 1997 - Jan 1998

Managed group of analysts responsible for clinical trials testing. Developed physical testing methods as well as analyzing products, methods supported new ANDA’s and NDA’s for transdermal drug applications supporting, drug applications which are the chief source of revenue. Trained clinical group in all aspects of finished product and raw materials testing and general laboratory procedures. Managed group of analysts responsible for clinical trials testing. Developed physical testing methods as well as analyzing products, methods supported new ANDA’s and NDA’s for transdermal drug applications supporting, drug applications which are the chief source of revenue. Trained clinical group in all aspects of finished product and raw materials testing and general laboratory procedures.