PD-QA Consulting LLC
Expert CMC, Quality & Regulatory Consultant for the Pharmaceutical Industry
About PD-QA Consulting LLC
PD-QA Consulting LLC brings over 30 years of industry expertise in product development, analytical development, quality control, quality assurance, and regulatory affairs to early and mid-stage pharmaceutical companies. Our mission is to demystify complex compliance landscapes and empower our clients to make informed strategic decisions that accelerate their path to market. We understand the unique challenges facing developing pharmaceutical companies and provide tailored solutions that balance regulatory requirements with business objectives.
Our team combines deep technical knowledge with practical experience across the entire pharmaceutical development lifecycle. From pre-clinical planning through Phase 3 development, we deliver strategic guidance and regulatory writing that positions our clients for success. We are committed to building long-term partnerships with our clients, serving as trusted advisors who help navigate the intricate regulatory environment and drive innovation forward.
Consulting and Writing Services
Product Development
Strategic planning and guidance for early to mid-stage pharmaceutical development programs. We help you navigate pre-clinical through Phase 3 development, optimizing timelines, resources, and regulatory pathways to accelerate your journey to market.
CMC
Comprehensive Chemistry, Manufacturing, and Controls consulting to optimize your drug substance and drug product development. We guide you through manufacturing processes, analytical methods, and quality strategies to ensure regulatory compliance and commercial readiness.
Regulatory
Expert regulatory writing and strategic guidance for CMC sections for regulatory submissions (IND, IMPD, NDA, MAA). Our experienced team crafts compelling, compliant documentation that communicates your product's safety, quality, and efficacy to regulatory agencies.