Dr Alan Touch
Raleigh,NC
Summary
Dynamic Principal and Senior Consulting Subject Matter Expert with over three decades of extensive experience in Regulatory Affairs, Product Development, Compliance, and Medical Writing. Demonstrated expertise in medical device and pharmaceutical development, successfully managing major regulatory submissions while leading cross-functional teams of subject matter experts. Achieved an impressive 240% growth in previous roles by ensuring compliance with global standards, including EU MDR and FDA regulations. Committed to delivering strategic solutions that enhance productivity and meet regulatory requirements, poised to provide significant value in challenging and fast-paced environments.
Overview
25
25
years of professional experience
Work History
Senior Technical Subject Matter Expert
GL Chemtec International
06.2025 - Current
- Small Molecule Formulation/Process Development and Polymer Chemistry Drug Delivery Development.
- Executive Business Consultant.
- Technical support and business development outreach.
Principal & Senior Consulting SME
624Advisors
01.2024 - Current
- Recent clients include Radiation Oncology combination Device-Drug-SaMD product, device extended-release drug delivery and an International major company Endocrinology Device/Drug as Medical Device Combination Product Device Regulatory/Clinical SME), Global Regulatory Affairs/Clinical Trial Roadmap Development, QMS, Compliance and document development SME.
- Dry Eye Solutions and Nutraceutical SME Consultant.
- Crisis audit review and Agency deficiencies action plan.
- Established relationships with key stakeholders for growth opportunities and successful partnerships.
- Regulatory Value Proposition Roadmap Development.
- Established Device role in Insulin drug CTA including protocol development EU CRO, and country regulatory requirements.
- Advisor for rapid Type I drug delivery and tech transfer.
- Created a roadmap for required regulatory documentation for the insulin clinical trial with the delivery device.
Founder, Principal Senior SME
624AdvisorsAvodex Partners
05.2013 - Current
- 624Advisors is an ongoing consultancy through which clients access Subject Matter Expertise and Strategic Advisory for the intersection of Product Development, Regulatory Strategies and Clinical Development and Implementation, delivered as hands-on day-to-day needs.
- Client experience over this period is, for the most part, consolidated as a seamless continuation of the mission of Avodex Partners with expanded service offerings as a partner where clients choose from a targeted menu of specialized regulatory and quality regulatory/clinical and compliance resources for specific targeted projects or backfill staffing as well as Center for Strategic Regulatory and Clinical Trial Stakeholder Roadmap Development.
- Projects and Contracts have included Senior Global Strategic and Operational (hands-on) Regulatory, Product Development, Clinical Development and Compliance Consulting for Targeted Pharma Therapeutics, Medical Devices, and Diagnostics and Combination Drug-Device Products.
- This includes Ophthalmology, Oncology, Neurodegenerative disease and processes, Dermatology, Infectious Disease, Respiratory, Inflammation and Auto-Immune Disease, Paediatric Cognitive Development & Wound Care, Cardiovascular, Women's Health, Nutraceutical Product Development, Biomarker Strategies, IVD Clinical Trial Management, Medical Device and Diagnostics Regulatory Medical Writing and Regulatory/Clinical Trial leadership, site feasibility and Clinical Quality Management and Quality Compliance.
- Key role in the creation of milestone Value Proposition product cost and timing RoadMaps for development, regulatory, pre-clinical, and clinical trial models.
- Provide multi-functional technical leadership for transitional regulatory submission stages and agency deficiency rescues or management for companies or investors.
Global Lead Regulatory Affairs SME and Manager
Baxter Healthcare International, Medical Products, Therapies
06.2022 - 12.2023
- Member of the multi-BU Baxter Global Regulatory Forum for challenging regulatory questions.
- Collaborates with the Regulatory Affairs Global Business Unit strategists and other cross-functional associates to support EU MDR submission strategies and ongoing SME needs to support CE Mark under EU MDR.
- Provides strategy and tactical input to cross-functional partners (i.e., R&D, Quality, Medical Affairs, Manufacturing, Product Development Owner etc.) driving right first-time submissions for CE Mark and upgrades from MDD to MDR.
- Reviews regulatory content for claims support of promotional material, labeling content, product and process changes, and product documentation.
- Represents Company with EU Notified Bodies Baxter teams including submission and deficiency report support.
- Ensures compliance with and contributes to the optimization of regulatory departmental policies, procedures, and records per applicable regulations and standards.
- Ensures the timely and accurate submission(s) of regulatory documentation, along with suitable and precise responses to deficiencies.
- Coordinates leading cross-functional partners on responses, as necessary.
- Identifies and communicates risks and mitigations associated with regulatory strategies to cross-functional partners including reviews for 38 applications of SaMD regulations for GAP and classification.
- Provides EU MDR expertise to functional and cross-functional team members including requirements across workstreams for GSPR (i.e., ISO 62366, ISO 10993, Post Market Surveillance, Post-Market Clinical Follow-up Plan and Report, Clinical Evaluation Reports, etc.).
- Interprets application of standards, regulations, and directives to ensure regulatory compliance.
- Authors impact assessments to external standards as required.
- Worked with such tools as VeevaVault.
Senior Regulatory Affairs and Compliance Architect & Lead Medical Writer
Wipro, Ltd
09.2018 - 12.2021
- Lead Global Quality Assurance/Regulatory Affairs, Global CRO Management Services, Clinical and Regulatory Compliance and Quality Assurance global teams.
- Pharmaceutical and Medical Device Clinical Quality Management Planning and execution from Feasibility through site qualification, site audits and training and mid-study compliance review.
- Quality Management Systems reviews, Gap Analysis and remediation, development and SOP development and audits.
- Management of EU MDD to MDR and IVDD to IVDR Regulatory Strategies, Technical Documentation (Technical File) GAP analysis and remediation including reviewing and writing of CER and other pre-CER technical documents for review by regulatory authorities.
- Participated in IVD Classification decisions, UDI traceability, IVD Risk Management Planning and Reports, PMS for IVD leading to PER and PMPF strategies.
- Advisor for IFU harmonization and Post-Market Surveillance Planning and implementation and lead for remediation for Class IIb and Class III devices and Class B-D IVDs.
- Product Lifecycle Management strategies, medical communications, post-market complaint and adverse event management, blogs, and structured regulatory documents for EU, China and US.
- PMA and 510(k) document and section development and writing.
- Work on SaMD regulatory and development strategies with AI and machine learning engineers as part of pilot program with US FDA.
- Global product registration management.
- COVID-19 EUA, NIOSH and FDA 510(k)s for medical device surgical masks, N95 respirators, Diagnostics tests for EUA, 510(k) clinical trials and submission.
- Validation Lead for Data and Analytics program implementation.
- Lead on Validation Plan, CSVR Plan and Validation Report for IQ, OQ, PQ and UAT.
Director of Product Development Program Management
ProPharma Group
07.2016 - 10.2017
- For Senior Leadership to introduce Program Management of Product Development in pharmaceuticals, biotechnology and personal medicine, medical devices and diagnostics.
- Clinical Compliance, regulatory strategies, program design, budgeting and oversight development of internal strategies, targeted services offerings such as medical writing for risk assessment and CER development, Investigator Brochures, sections of submissions.
- Creation of GCP audit design and compliance with emphasis on biomarkers, preclinical studies design and management, clinical development planning including the Clinical Quality Management Plan.
- Liaison to Professional and Clinical Development Community.
- Writing, Presentations and Publishing relevant articles and blogs.
Principal Strategist, Director level
INC Research, Syneos Health
06.2010 - 05.2013
- Led Development and Growth of Global Medical Device, Diagnostics and Ophthalmology Group.
- Guided Company Global Ophthalmology, Medical Device and Diagnostics Regulatory Consulting and Submissions Strategies for all regions.
- Collaborated on Drug/Device and device global regulatory and clinical trial management.
- Led group to attain 240% in three years.
- Demonstrated client success and satisfaction.
- Managed cross-functional and cross-therapeutic matrix of responsibilities across functional and multi-therapeutic areas on a global scale for Clinical Trials and Regulatory.
- Global responsibility as a resource for all Medical Device, Diagnostics and Drug Delivery Regulatory Strategies and Submissions.
- Supported BD and corporate in the establishment of key relationships in MDDO space.
- Created specialized Medical Device & Diagnostics targeted clinical trial models and budgets and customer tools.
- Managed Large Scale Global Clinical Trials in Ophthalmology Drug Development including Eylea.
- Created specialized biomarker and sample collection models, Initiated and supported development of Risk Based Monitoring Model including selective approaches to SDV sampling and mix of on-site and central monitoring and data management.
- Developed clinical trial study and budget models for Diagnostics Verification (ROC curves) and Validation for diagnostic and predictive outcomes.
- Co-developed Medical Device Post-Approval model for Feasibility, Risk Analysis, Action Plans and protocol development targeting both post-market surveillance requirements and evidence-based reimbursement or marketing studies as one arm or comparative study design.
- Created novel Human Factors Engineering and Instructions for Use clinical trial models.
Chief Science Officer
Corneal Science Corporation A CDMO
01.2001 - 05.2010
- Leadership of a growth-oriented small ophthalmic pharmaceutical and medical device development, manufacturing, and distribution company.
- Successful leadership of ophthalmic OTC and Rx drug development program for own product and contract formulation and manufacturing of private label or contracted ophthalmic liquid Rx and OTC products as CDMO.
- Supervision of all functions: product development, global regulatory strategies and execution, aseptic manufacturing scale up, and cGMP including QMS, complaints, compliance, and commercialization.
- Responsibilities included Product Development, Formulation and Process Development, Strategic Business Planning, Budgets, P&L, Balance Sheet and Cash Flow reviews, funding requirement reviews and staff performance review model and action plans.
- Led team for development of drug formulation and aseptic manufacturing processes for liquid topicals and ear products.
- Co-developed first IVD using tears as the bodily fluid testing for proteins and antibodies.
- First approved FDA submission and CLIA reimbursement for ophthalmology IVDs.
- Prior Company as Chief Science Officer and investor led the Development of the first approved soft lens with permanent colorant, creating a new segment.
Education
Doctor of Optometry (OD) -
Indiana University
Bachelor of Arts - Psychology
University of Iowa
Skills
- Regulatory/Clinical Development and Compliance Hands-On
- Strategic Reg/Clinical/Compliance Roadmap
- Milestone Value Proposition Analytics
- Multi-national and Entrepreneurial emerging growth Experience
- Therapeutic Program Management
- Quality Management Leadership
- IVD and Diagnostics Project Management
- MDR/IVDR Technical File Development
- SaMD hands-on Regulatory Strategies
- GAP analysis
- Usability
- CER/PER
- Regulatory Medical Writing
- Clinical Quality Management Planning
- Site ID
- Feasibility
- Qualification
- Product Development Leadership
- Regulatory
- Risk Management Compliance
- Drug-Device Combination Products
- Effective Communicator
Expertise
Early Stage/Mid-Size Regulatory/Clinical Development, Strategic Milestone-Based Roadmap, Therapeutic Device/Drug Delivery and CDx Combination Program Management & Quality Management Leadership, SaMD Determination and regulatory compliance, IVD and Diagnostics Project Management and Strategic regulatory and clinical leadership, Regulatory and Clinical Experience including Compliance GAP Analysis, Remediation for QMS, Technical Files, EU US regulatory body filings, and communications, Regulatory and Medical Affairs Medical Writing for submissions and compliance, Clinical Quality Management Planning and Implementation, Strategic Regulatory and Clinical Trial Roadmap, Global Regulatory/Clinical Development SME, Medical Device, MDR/IVDR, targeted pharma and IVD diagnostics/combination products, Biomarkers as Drug Development Tool, Clinical GCP/GLP compliance
Languages
English
Native or Bilingual
Timeline
Senior Technical Subject Matter Expert
GL Chemtec International
06.2025 - Current
Principal & Senior Consulting SME
624Advisors
01.2024 - Current
Global Lead Regulatory Affairs SME and Manager
Baxter Healthcare International, Medical Products, Therapies
06.2022 - 12.2023
Senior Regulatory Affairs and Compliance Architect & Lead Medical Writer
Wipro, Ltd
09.2018 - 12.2021
Director of Product Development Program Management
ProPharma Group
07.2016 - 10.2017
Founder, Principal Senior SME
624AdvisorsAvodex Partners
05.2013 - Current
Principal Strategist, Director level
INC Research, Syneos Health
06.2010 - 05.2013
Chief Science Officer
Corneal Science Corporation A CDMO
01.2001 - 05.2010
Bachelor of Arts - Psychology
University of Iowa
Doctor of Optometry (OD) -
Indiana University