K.A. Ajit Simh

Just over forty (40) years of experience in the field of biopharmaceuticals, active pharmaceutical ingredients (API), biologics, oral solid dosage forms, ointments, parenterals and class I and II medical devices. Experience includes regulatory compliance, Quality Control and Quality Assurance of biologics and drugs to include non-clinical safety studies in compliance with US FDA and OECD principles and GCP’s. Active in academia as an adjunct professor at San Diego State University in the Graduate program and Instructor at the University of California, San Diego since the mid 1990’s and a member of their advisory boards.

Ajit has worked for multi-nationals – Mallinckrodt Inc., Baxter Healthcare Corporation and Abbott Laboratories. He established Shiba Biotechnology Inc., in 1999 to provide services to the pharmaceutical and biotechnology industry in regulatory compliance strategy and quality. Over the years he has hosted US FDA GMP, EMA and BIMO inspections successfully and prepared several companies for hosting

Pre-Approval Inspections (PAI) in the USA and internationally.

PROFESSIONAL EXPERIENCE

Overview

As a Senior advisor, strategist and consultant provide expertise in the areas of Regulatory Compliance and Quality to assist in: a) the establishment and due diligence of API and dosage form manufacturer’s (oral solid’s, ointments, parenterals and biologics) for compliance with US FDA and European regulatory requirements, b) conducting GLP (non-clinical safety studies per 21 CFR 58), compliance training and audits and c) GCP clinical site compliance training and audits to include clinical site qualification. In addition to experience in the US, worked with API, dosage form and Class I and II medical device companies in Austria, Belgium, Canada, Czechoslovakia, China, Finland, France, Germany, India, Italy, Japan, Malaysia, The Netherlands, Poland, Spain, Slovenia, Switzerland, Taiwan, UK and the USA.

Summary of Work Experience:

Over the past 40 years worked and consulted in roles of increasing responsibility at Abbott Biotech. (Pharmaceutical Products Division), Arena Pharmaceuticals, Avid Bio Services, Baxter Health Care (Dade and Renal Divisions), Biocon, BiogenIdec, Bristol Myers Squibb, Chiron Corporation, Cytel, Corporation, Daiichi Sankyo (Corporate auditor), Gilead Sciences, Jeff Yuen and Associates, Mallinckrodt, Pacira Pharmaceuticals, Regado Biosciences and

Peregrine Pharmaceuticals and other biotechnology and pharmaceutical companies.

Since 2003 and most recently have conducted several mock PAI’s and hosted US FDA (GMP and BIMO) and EMA Inspections (for API (small and large molecules) and finished dosage forms

(oral and parenteral) with successful outcomes. In addition, have conducted facility design review

per US FDA and EU requirements, and training in current Good Manufacturing Practices and ICH Q7.

Have conducted several clinical site audits for compliance with US FDA regulations and protocol compliance at Phase I units and CRO’s in preparation for BIMO inspections.

Shiba Biotechnology Consultants Inc. La Jolla, 4/1999 – Present
California, USA

Provide a high-level consulting consortium of services in regulatory compliance and quality systems strategy to pharmaceutical and biotechnology companies in Europe, India and the USA. Recently spear headed the successful completion of Pre-Approval Inspections (PAI) in the USA, Europe and India to include GMP, GLP and GCP compliance. Worked nationally and internationally in conducting due- diligence audits / inspections to evaluate and support, US FDA, WHO, HPB, SwissMedic, and EMA inspections. Provide regulatory compliance support with draft responses to US FDA’s 483 observations and Warning Letters to pharmaceutical companies in Europe, India and USA. In addition, assist companies with facility / business due-diligence review for product licensing / acquisition. Conducted innovative training sessions and workshops in GCP, GLP, and GMP requirements and compliance and performed training of cGMPs required at companies operating under FDA’s consent decree. In early stage development companies established quality systems for operating in compliance with US FDA regulations and guidelines for the requirements and the production and control of clinical supplies manufacturing. Act as liaison between the regulatory agency (FDA, EMA, HPB, etc.) and the sponsor. Provide leadership role at companies to identify and hire personnel in quality assurance, quality control, regulatory affairs, regulatory compliance, validation, and materials management.

EDUCATION

M.S.(Research)., Cell Biology / Immunology, St. Louis University, St. Louis, MO  1974-1975

 

AFFILIATION WITH PROFESSIONAL SOCIETIES AND ACADEMIC INSTITUTIONS

  • Member of the Advisory Board for Bio-Pharm International
  • Parenteral Drug
  • Advisor and instructor teaching Biomedical Quality and Regulatory Compliance courses in the Department of Bio-Science at the University of California, San Diego since
  • Adjunct professor since 1997 in the Center for Bio-Pharmaceutical and Bio-Medical Devices at San Diego State University, teaching courses (GMPs for biologics, drugs and medical devices and quality assurance and control for biologics and drugs) for graduate studies – M.S. in Regulatory

7486 La Jolla Blvd. # 571, La Jolla, CA 92037, USA | Office Phone: 858-551-8590 | Mobile: 619-339-4488 | email: aj@shibaquality.com | sdsimh@yahoo.com

ASSOCIATES

Judy M Atkins, RN, RPH, PHARMD

PROFESSIONAL SUMMARY

Dr. Atkins has been affiliated with Shiba Biotechnology Inc. as a Subject Matter Expert in Good Clinical Practice (GCP) since 2016.

Dr. Atkins has over 30 years of experience in the pharmaceutical industry. Her diverse experience includes management of all aspects of the drug development process, including development of drug and biological products, development and implementation of quality systems, manufacturing (formulation, clinical supplies, and commercial scale-up and launch), Clinical Operations, Regulatory Affairs, and Corporate Quality and Compliance.

At Baxter, she served as Senior Technical Development Manager. Through corporate partnerships and joint ventures with Nestle SA and Pharmacia AB, she participated in the global development and market launch of several important drugs and medical devices, including pre-mixed “ready to use” intravenous drug products, intravenous drug emulsions, parenteral and enteral nutritional products, automated compounding technology, non-drug binding filters, electronic infusion devices, and blood products. She was also part of the start-up management team for three pharmaceutical companies. She subsequently worked for five years within the CRO industry, establishing the Clinical Operations Department and Office of Compliance for a leading Contract Research Organization.

In 2000, she co-founded Compliance Resources LLC, a consulting business specializing in providing strategic product development, regulatory, quality, and compliance services to the global pharmaceutical industry.

She received her Bachelor of Science, Master of Science and Doctor of Pharmacy degrees from the University of North Carolina at Chapel-Hill. As part of her doctoral studies, she was privileged to be assigned to the Office of Health Affairs, Office of the Commissioner, U.S. Food and Drug Administration (1998). Dr. Atkins is the author of The Clinical Trial Manager (Fifth Edition, Sunset Publications, Inc.) and The Clinical Trial Manager:  Casebook (A companion to the Fifth Edition, Sunset Publications, Inc.).

Compliance Resources LLC services including:

  • Providing guidance to the pharmaceutical industry regarding product develop programs (eg, drugs, biological products, nutritional product, medical devices), clinical operations, and corporate quality
  • Providing guidance on clinical operations and clinical quality assurance, with emphasis on systems, processes and FDA inspection readiness
  • Preparing regulatory submissions and medical writing (eg, Orphan Drug Applications, INDs, CTD/eCTD, Clinical Study Reports, PSURs, DSURs)
  • Preparing annual PDUFA, GDUFA registration and listings
  • Registering Clinical Trials with clinicaltrials.gov and submitting updates as required;
  • Preparing FDA Meeting requests and information packages, coordinating FDA meeting rehearsals, and attending FDA meetings
  • Serving as the U. S. Agent for pharmaceutical companies and establishments located outside of the United States
  • Working on-site at established and emerging pharmaceutical companies to develop infrastructure (eg, develop and/or harmonize corporate SOPs, develop corporate audit plan, create Central Document Room and Recordkeeping/Retention Standards)
  • Working on-site to develop and oversee the implementation of Quality System including, but not limited to, provide company-wide ISO training, develop corporate Quality Manual, establish Management Review Committee, work with individual departments to define and document processes (eg, ISO 9001, ISO 13485, ICH Q10)
  • Verifying the eligibly of institutions, IRBs, investigators, monitors, contract research organizations, and other entities to conduct clinical research
  • Monitoring of Phase 1 – 4 clinical studies
  • Conducting Vender Qualification and Re-qualification Audits
  • Conducting GCP audits of sponsors, CROs, Institutional Review Boards/Ethics Committees, Investigators, Monitors, Data Management Organizations, and Phase 1 Units
  • Conducting GLP audits of nonclinical laboratories
  • Conducting cGMP audits of pharmaceutical manufacturers, contract manufacturing organizations and testing laboratories
  • Conducting GVP audits (i.e., risk-based pharmacovigilance system audits and audits of the quality system for pharmacovigilance activities as governed by the European Medicines Agency; all audits international; most in UK)
  • Recommending and implementing corrective actions when deficiencies are noted during GCP, GLP, and cGMP audits
  • Conducting ‘Mock’ FDA Pre-Approval Inspections (PAI) and implementing remediation plans (ie, corrective action plans) in advance of FDA inspections; and
  • Providing GCP, CLP, cGMP and Pre-approval Inspection Readiness training

Lakshmi Achuta, M.Sc

  • Lakshmi Achuta is a Quality and Compliance professional with combined knowledge, expertise and skill in implementing, integrating and auditing multiple standards in disparate management systems (GXP, ISO) having 27 years of experience in Biotechnology, Biopharmaceutical, Clinical Research (CRO), Contract Research and Manufacturing Services (CRAMS) industries spanning early drug discovery and development laboratories, manufacturing, pre-clinical and clinical research.
  • She has led, managed and guided cross-functional teams during various types of audits: certification audits for the various management systems, regulatory inspections (USFDA, EMA, ANVISA, PMDA, BARDA, CAP among others); audits for – customer / sponsor (multi nationals, third party consultants, Qualified Person – QP), due-diligence, loss prevention-business risk, CSR, confidential information, data integrity, asset protection audits.
  • She is a consultant faculty for Biocon – Keck Graduate Institute Biosciences program, Biotechnology Skill Enhancement Program (BiSEP); Biocon – Ramaiah Quality Control Analytical Program; Cellular & Molecular Diagnostics of Biotechnology Skill Enhancement Program (BiSEP).
  • She earned her M.Sc (Applied Botany – Medicinal & Aromatic plants) from Bangalore University and M.S. (Quality Management) from BITS (Birla Institute of Technology and Science), Pilani.

Vid Barve, PMP

INFORMATION TECHNOLOGY PROFESIONAL
Strategic Information Technology leader with extensive experience as a Business Partner. Understands business goals and translates those needs into strategy and roadmaps. Extensive experience working in regulated environments. Key areas of expertise include:

Veeva Vault Admin Certified • Business Relationship Management • Enterprise Application Management • Strategic Planning • Team Management • Project Management • Cross-Functional Team Leadership • Vendor Management • ERP (SAP, QAD) • Manufacturing Execution Systems • EDMS (Veeva, TCE, Agile, SAP) • (QMS Systems (Veeva QMS, ETQ)

TP Narayan, Ph. D

An established Consultant with 35 years of experience in Quality, Compliance, Validation, and Regulatory CMC in the Pharmaceutical / Biotechnology / Medical Device industry. Specific areas include development of QA/QC Quality Systems (21CFR, FDA, EU and ISO Guidelines), QC Laboratory Controls, Document Management and Control, Compliance Audits, Deviation, OOS, CAPA investigations, Data integrity, Remediation, Risk Assessment, Qualification / Validation of Equipment and Processes, Design, review, and approval batch records, Review of medical device history files, Trend Analysis, Training and Development (cGMP, Test Methods and Processes, Agency Audits and Inspections), Technical Writing (SOP, Validation Protocols and Reports, and Test Methods), Product Compliance (Complaint investigation, documentation, processing, tracking, trending and reporting), Stability Studies (Testing Program, protocols, and reports), Analytical Validation (Method Development, Method Validation, Method Transfer, Cleaning Validation), Aseptic Manufacturing (Media fill studies, decontamination of aseptic area), Regulatory Submissions (CMC sections in DMF, IND, NDA, ANDA),
Active Pharmaceutical Ingredient (Process Development/Technology Transfer).

David Pudwill

David Pudwill served as a Senior Director of Regulatory Affairs at ConvaTec from 2018 to 2021, and before that as a Director of Regulatory Affairs and Quality Assurance at ConvaTec from 2017 to 2018. David is a founding member of the Kidney Health Initiative (a partnership between FDA and ASN). He has helped startups acquire funding and achieve successful IDE and 510(k) submissions to FDA. David held various roles at FDA from 2008 to 2017, including Branch Chief of the Implantable Electrophysiology Devices Branch, Lead Medical Device Reviewer in the Gastroenterology and Renal Devices Branch, and Congressional Affairs Specialist in FDA’s Office of Legislation. Prior to joining FDA, David worked at St. Jude Medical from 2006 to 2007 supporting the Cardiac Rhythm Management Division. David earned his Bachelor of Science in Engineering degree in Biomedical Engineering from Case Western Reserve University in 2006, and earned his Master of Mechanical Engineering degree from Johns Hopkins University in 2014.