Mr. PNB Varma

Founder & Chief Networking Officer

ISO 13485 Medical Device certified lead auditor at URS India ISO certification body

Mr.PNB Varma holds a Master Degree in Chemistry from SA university, Rajasthan and a Post-graduation in Management from Symbiosis University. Obtained various GMP, ISO and technical certifications in Pharmaceuticals. As a Quality, Technical expert, Mr.Varma has over 22 years of experience in dealing with manufacturing of Finished dosage forms Viz., Tablet manufacturing, Capsules etc., other various formulations, Chemicals, Nutracuticals, Active Pharmaceutical Ingredients related industries worked with companies like Dr.Reddys Labs, Aurobindo Pharma Limited, Laurus Labs Private Limited, Apicore US LLC, Vadodara (US based company) headquarters located at New Jersy, USA) and few other pharma majors in India. His experience includes Quality Assurance & Control, Manufacturing, RA support, DMF review, Validations, Regulatory compliance & Auditing. In addition to substantial knowledge of regulations, including cGMPs (21 CFR 210 & 211 & 117), EU GMPs for Medicinal Products, Australian Code of GMP for Medicinal Products, Varma has experience in subject matter expertise in QMS area Viz., Developing VMP, equipment and facility qualifications, batch record reviews, failure investigations (Laboratory & Manufacturing), handling of deviations, change control management, OOS, CAPA management, market complaints, GMP training, internal audits & handled various customer & regulatory audits.
HACCP qualified and trained professional and imparted to manufacturing personnel on implementation of HACCP systems in the site. Identified various Critical control points (CCP’s) in the manufacturing processes. CCP’s are critically monitored and categorized as per HACCP methodology during the entire tenure (developed spread sheets for each and every mfg.operation before any CCP was identified). Done risk assessment study and applied risk rating to assess and control of the processes for any impact. Faced many audits from major customers from US, Europe and SE asia region.
Strong leadership skills and executive presence. A dynamic senior training executive with broad domestic and international experience as a managerial culture change agent. Proven ability to work effectively from the executive suite to front line scientists and technicians. Versatile training using all of the contemporary tools available.
Expertise in Pharmaceutical, Medical Device and Biotech areas: Operations and Strategy, Patient Safety Compliance, Standards, Inspection Readiness Prep, Audits, Vendor Oversight, GxP Training and Learning Solutions, Quality Management, Quality Systems, Manufacturing, Supply Chain, R&D, Clinical and Quality Control.

V Ramesh

Quality Practitioner

Professional(developed profile as quality practitioner) with 23+ years of experience in FDA/EU-related expertise with Good Manufacturing Practice (GMP) regulations, Quality System Regulation (QSR) and Part 11;EU GMP Annex 11 regulations in leading the Total Quality Management as per cGMP, GLP, GCP in concordance with current USFDA, EMA,MHRA, PIC(s); UK MHRA;TGA;MCC WHO-GENEVA-PQP; ANVISA and PMDA Japan authorities guidelines for the Good Manufacturing of products and services of Pharmaceutical industry including API and Dosage form(OSD and sterile).

Exposure in Medical devices (ISO13485);Food Standards; Neutraceutical; Supplements and ISO9001QMS

Exhibited ownership in leadership for acquiring new accreditations to its break free maintenance with remediation for the audit and compliance for the organization from various regulatory authorities for the clients.

Well versed with the current regulatory requirements; a good trainer cum executer coach for making team ready for audit and compliance in ALL THE TIME READYNESS (ATR)

Expert in Data integrity Audits and solutions provider.

C Schwartz

Biomedical/Quality Engineer-Medical Devices with 20-plus years of varied experience managing Class I, II, and III medical devices

Biomedical/Quality Engineer-Medical Devices with 20-plus years of varied experience managing Class I, II, and III medical devices, from concept through market release. Identified and resolved product performance issues. Prepared technical portions of FDA submissions in the private sector, and evaluate IDE & PMA supplements and 510(k) submissions for clearance at FDA as a lead reviewer. Skilled in Quality Assurance, design controls, preclinical safety and effectiveness testing, QSR (820 requirements), Regulatory Affairs, risk assessment, implementation, product improvement, and marketing.
Effective establishing relationships with interdisciplinary teams and making technical presentations.

Quality Engineering, Regulatory and Compliance Product Improvement
• Risk assessment development (e.g., FMEA) • Corrective and Preventive Actions (CAPAs)
• SOP, protocols and report development • Complaint investigations & root cause analysis
• Creating and mentoring Design History Files • Biocompatibility & Human Factors testing
• Preclinical in vitro and animal testing • Fabrication methods for plastics and metals
• IDE, 510(k), PMA, De Novo preparation support
• Managing tasks & projects to timelines

Venkatadri Bobba

Scientific Advisor

A General Partner with Ventureast, Bobba brings over 36 years of corporate leadership experience in the pharmaceutical and life sciences fields in the US, EU and Asia. He is an active board member of three US and India based portfolio companies namely, Diabetomics Inc., USA, Richcore, Bangalore and Portea , a home care company based in Bangalore. He also serves on the Board of wholly owned Subsidiary of Cancer Genetics , a NASDAQ listed company in USA.

VENKAT VISWANATHAN

Senior Executive with expertise in all aspects of technical operations

Dynamic, accomplished senior executive with expertise in all aspects of technical operations for highly regulated industry-leading pharmaceutical manufacturers including Pfizer and Parke-Davis. Exceptional skill in managing and directing global operations and cross-functional project teams that support commercial manufacturing organizations through sourcing strategy, technology transfer activities, process improvements, and process validation. Significant contributions toward ensuring quality and continuity in foreign facilities in Asia, Latin America, Europe, and Puerto Rico. An outstanding team leader with the ability to lead and inspire high performing teams

W Hassel

Medical Device Consultant, 30 years experience: design, compliance, quality, risk management, regulatory

• Project leader and team player with over 20 years experience in medical device R&D, quality systems, and regulatory affairs. Client base from start-ups to major multinationals.
• Adaptive, eclectic, proven skills encompass such state-of-the-art and cutting-edge technologies as in vitro diagnostics, critical care catheters, computed tomography, automated human stem cell production, hemodialysis, vascular implants, infusion pumps, neuromuscular electrophysiology.
• Successful mitigation of FDA enforcement actions (warning letter, 483, recall), medical device submissions, quality systems design, and remediation of quality system and design control deficiencies.
• Extensive knowledge and application of FDA QSR & cGMPs and ISO 13485.
• Extensive work in Risk Management per ISO 14971, and hazard/failure analyses including software.
• CAPA management, investigation, and remediation,
• Life cycle product development per design controls: initial technology concept, user needs analysis, product development, R&D engineering, design validation, manufacturing transfer, and process validation.
• Multidisciplinary technical and design background including biomedical, systems, software, electrical, and mechanical engineering.
• Successful start-up of two medical device companies as founding partner.


Specialties: Medical Device product development, R&D, engineering;
Regulatory Affairs, compliance, submissions;
Quality Systems: QSR, cGMP, ISO 13485;
Design Controls;
Risk Management & hazard/fault/failure analyses;
CAPA management;
Underwriters Laboratories marking

KA Woolman

Senior Associate, Technical Operations Training

Strong leadership skills and executive presence. A dynamic senior training executive with broad domestic and international experience as a managerial culture change agent. Proven ability to work effectively from the executive suite to front line scientists and technicians. Versatile training using all of the contemporary tools available.
Expertise in Pharmaceutical and Biotech areas: Operations and Strategy, Patient Safety Compliance, Standards, Inspection Readiness Prep, Audits, Vendor Oversight, GxP Training and Learning Solutions, Quality Management, Quality Systems, Manufacturing, Supply Chain, R&D, Clinical and Quality Control.

Peter E. Smith, Ph.D.

Senior Associate for GLP/GCP Compliance

Specializing in the support of pharmaceutical research/development and regulatory affairs including: regulatory liaison with reviewing division; regulatory liaison with orphan products; regulatory submission development and support; study report review; investigational site inspections, facility inspections, study documentation audits, training for research and quality assurance professionals, mock FDA inspections and computer validation.
Consulting Experience:

• Contracts with over 50 sponsors since 1996
• Areas of support included:
• Clinical research and development
• Monitoring
• Clinical protocol development
• Investigator brochure development
• Clinical study report preparation
• Non clinical research
• Contract vendor qualification
• Quality assurance support
• Regulatory Affairs
• Regulatory submission development support including INDs, NDAs and BLAs
• Participation and support of Type B meetings with Center for Biologics
• Liaison with agency representatives from Center for Biologics
• Liaison with agency representatives from Orphan Products division
Specific Client Experience in Regulatory Affairs

Philip M. Fantasia, B.A., MBA, RAC

Senior Associate

Seasoned consultant providing expert professional services in regulatory and product development strategy, pre-market and market regulatory submissions, GxP compliance auditing, and cGMP implementation to medical device, biologics, and pharmaceutical companies in the US, Canada, and Europe.