We are smart, deliberate, and focused; offering a confident, honest, and approachable end result. Composed of senior, industry-experienced consultants and leaders in the scientific, technical, and business disciplines, Protocol Link offers the best of both quality and efficiency. It’s how we’ve been doing business since 1996. The right way.

Dipak Doshi, CEO

Dipak Doshi

Chief Executive Officer & Chairman

Dipak Doshi is the Chief Executive Officer of Protocol Link. Mr. Doshi has over 30 years of experience in the pharmaceutical, biotechnology, and medical device industries. He has extensive experience in parenteral drug manufacturing, cGMP compliance strategies, cGMP documentation systems, cGMP compliance audits, PAIs, CAPA system development, TrackWise validation, validation master plans, process validation, critical system validations, equipment qualifications (IQ, OQ, PQ), computer and software system validation, ERP system (SAP, MAPICS, J.D. Edwards) validation, cleaning validation programs, and CDER/CBER submissions.

Mr. Doshi has held several senior-level management positions in major pharmaceutical companies, directing development and implementation of cGMP compliance strategies and initiatives in support of marketed NDA products. He has performed NDA/ANDA gap assessments, developed product specifications, and written SOPs. Mr. Doshi has subject-matter expertise in APRs, site transfer strategies, process validation programs, personnel training, product assessments, FDA review and inspection liaisons, vendor audits, quality and technical agreements for contract manufacturing, product complaint investigations, and product recall management reviews. Additionally, he has managed audits covering drug manufacturing and testing sites throughout the USA, Europe, and Asia. Mr. Doshi received his M.S. degree in Microbiology & Genetics from Illinois Institute of Technology located in Chicago, Illinois, USA, and another M.S. degree in Industrial Microbiology from Gujarat University in India. Mr. Doshi is affiliated with PDA, ISPE, ASQ, and NRM.
Ginni Doshi, COO

Ginni Doshi

Chief Operating Officer & Vice Chair

Ginni Doshi is Chief Corporate Officer of Protocol Link. Mrs. Doshi has over 25 years of experience in the pharmaceutical, medical device/diagnostics and biotechnology industries, specializing in the areas of pharmaceutical drugs and medical device manufacturing, process and test method validation, FDA compliance audits, worldwide global supply chain audits of API vendors and contract drug product manufacturers, GMP documentation systems, training programs, US FDA regulatory submissions (ANDAs and NDAs), and quality systems management.

She has managed the planning, scheduling and resource allocation for development and implementation of a test method validation database. Mrs. Doshi has reviewed and approved batch records for product release from global countries (including from India, China, and Europe) that were destined for US market and US drug product distribution. She has performed numerous compliance audits worldwide in support of global manufacturing of clinical lots, exhibit batches, and validation lots. Mrs. Doshi has coordinated personnel training programs for GMP documentation and change control. She has performed test method and process validation execution in support of IND, PLA and PMA submissions for medical device and diagnostic manufacturing. Mrs. Doshi received her B.S. degrees in Medical Technology and Microbiology from Rush University in Chicago, and is affiliated with PDA, ASQ, and ASCP.
Steven Weltler, President

Steven Weltler


Steven Weltler is President of Protocol Link with 40 years of experience in the pharmaceutical and medical device industries. Mr. Weltler has significant expertise in the areas of non-sterile and sterile manufacturing operations, plant management, cGMP compliance, QA/QC, quality systems, production, process management, information technology, engineering, operations management, and process improvement implementation. He also has experience in the areas of business and compliance strategies, CAPA system development, facility and organizational assessments, inventory control, and supply chain management.

Mr. Weltler has assumed leadership responsibilities in coordination and implementation of projects in support of senior management needs of major pharmaceutical companies, including 12 years as Plant Director of Operations. Mr. Weltler has developed and implemented QSAP programs, GMP policies, and coordinated site FDA, EMEA, cGMP, and PAI inspections. He has held senior-level executive positions in managing programs for large scale, multi-million-dollar capital projects, including pharmaceutical facility expansions, process overhauls, major equipment installations, and systems and infrastructure upgrades within pharmaceutical and medical device environments. He has conducted dozens of GMP compliance inspections globally, has represented clients as FDA liaison both on-site and at FDA district offices, and has led the creation and implementation of compliance improvement processes in multiple pharmaceutical companies.

Mr. Weltler has a B.S. in Operations Management from Western Illinois University and is affiliated with PDA and ISPE.

Daniel Hoch, Ph.D.

Daniel Hoch, Ph.D.

Chief Scientific Officer

Daniel Hoch, Ph.D., is Chief Scientific Officer with Protocol Link and has over 30 years of experience in the pharmaceutical, medical device and FDA-regulated industries. During his tenure in the industry, Dr. Hoch has held senior management positions in Quality, Compliance, Laboratory Operations, and Regulatory Affairs. He has carried leadership responsibilities in coordination and implementation of multiple regulatory affairs projects with a focus on Registered US Agent support, FDA liaison, paper and electronic (eCTD submissions via ESG) regulatory submissions including DMF, IND, NDA, ANDA, 505(b)(2), 510K, supplements and annual reports, and DDMAC expertise.

Dr. Hoch has expertise in developing specifications, establishing process and cleaning validation, conducting test method validation and laboratory OOS investigations, and managing annual product reviews, product release, and recalls. He has managed R&D and QC laboratories for raw material, in-process, finished product, and stability testing. Dr. Hoch has performed cGMP and QSR compliance assessments for NDA, ANDA, PLA, and BLA submissions as well as 510K and regulatory compliance for medical device and diagnostics operations. He has served as the lead auditor for GMP audits of third party contract manufacturers. Dr. Hoch has performed site readiness inspections in preparation for FDA general inspection and PAI audits, as well as served as the on-site liaison to FDA investigators. He has experience in APIs and manufacturing of pharmaceutical liquid, solid, and parenteral drugs. Dr. Hoch received his Ph.D. in Analytical Chemistry from Purdue University and is affiliated with PDA, RAPS and ISPE.
Ankit Patel, Director

Ankit Patel


Ankit Patel is a Director with Protocol Link with over 15 years of experience in pharmaceutical, biotechnology, and medical device industries. Mr. Patel has implemented Enterprise Resource Planning (ERP), Electronic Document Management System (EDMS), and proprietary software systems (ISI eCTD Express, Johnson Controls, TrackWise, etc.). Mr. Patel has managed validation of facility equipment, process equipment, corporate networks and ERP (SAP, MAPICS, and Maximo) systems in variety of pharmaceutical and biologic companies.

Mr. Patel has expertise in the areas of systems design, HVAC systems, BMS systems, purified water systems, cGMP compliance, parenteral and solid dosage manufacturing, and technical writing and has experience as an Interim Facilities Manager for a biologics manufacturing site. Mr. Patel has successfully prepared, managed and submitted multiple electronic regulatory submissions according to the eCTD lifecycle guidelines through the FDA Electronic Submission Gateway (ESG). Mr. Patel received his B.S degree in Chemical Engineering from New Jersey Institute of Technology and Hands-on Aseptic Processing training from PDA. He is affiliated with PDA, ISPE, and AIChE.
David McGregor, Ph.D, Director

David McGregor, Ph.D.


David McGregor, Ph.D. is Director with Protocol Link. Dr. McGregor has 25 years of experience in the pharmaceutical, biotechnology, and industrial chemical industries. During his tenure in the industry, Dr. McGregor has held senior management positions in Validation Laboratories, Product Compliance Laboratories, Analytical Laboratory Operations, and Regulatory Affairs. He has carried leadership responsibilities in coordination and implementation of multiple regulatory affairs projects a focus on DMF, and ANDA and supplements and annual reports, as well as eCTD submissions. He has lead CMC teams for remediation of Latin American dossiers.

He has acted as technical and/or strategy lead for European and Latin American dossier modernization efforts in support of the product lifecycle. He has experience in APIs, solid dosage forms, parenteral, and biologics. He has managed Analytical Laboratories that develop, optimize and validate analytical methods in support of excipient production and release in the chemical and pharmaceutical industry. Dr. McGregor received a B.S. degree in Chemistry from Northern Illinois University and a Ph.D. in Analytical Chemistry from Iowa State University. He is affiliated with AAPS, American Chemical Society, ALMA, and PDA.