Why we are your ideal partner (为什么我们是你们的理想伙伴）
Who we are
With a distinguished career as a senior pharmaceutical scientist and FDA senior reviewer, Dr. Youmin (June) Wang brings extensive expertise in drug development, regulatory affairs, and quality assurance. With a passion for advancing healthcare and ensuring the safety and efficacy of pharmaceutical products, Dr. Wang has dedicated her professional life to making a positive impact on the industry. She started the Silver Spring BioPharma Consulting, LLC in late 2022. By working with her like-minded colleagues, they provide services tailored to meet the specific needs of pharmaceutical companies, research organizations, and healthcare professionals
What we offer
At Silver Spring BioPharma Consulting, we provide comprehensive and strategic consulting services tailored to meet the specific needs of pharmaceutical companies, research organizations, and healthcare professionals. Leveraging our vast experience and deep understanding of regulatory requirements, we offer the following services:
- Regulatory Strategy Development: Navigating the complex landscape of regulatory affairs is crucial for successful drug development and approval. We provide valuable insights and guidance in crafting robust regulatory strategies, ensuring compliance with FDA regulations and international standards. We assist in preparing regulatory submissions, addressing questions from regulatory authorities, and optimizing strategies for efficient product approval.
- FDA Interaction and Advisory Services: Having served in the FDA in various senior roles, our consultants possess an insider's perspective on the agency's processes and expectations. We offer expert advice and support in preparing for FDA meetings, including pre-IND, end-of-phase meetings, and pre-NDA/BLA/ANDA interactions. Our goal is to help clients effectively communicate their research findings, address concerns, and optimize their chances of obtaining regulatory approval.
- Quality Assurance and Compliance: Maintaining stringent quality assurance practices is paramount in the pharmaceutical industry. We provide guidance on establishing robust quality systems, implementing good manufacturing practices (cGMP), conducting audits, and ensuring compliance with FDA regulations and guidelines. We help clients identify potential gaps, develop corrective action plans, and enhance overall compliance and product quality.
- Drug Development Support: From preclinical development to post-marketing activities, we offer comprehensive support throughout the drug development lifecycle. Our consultants assist with study design, protocol development, data analysis, and interpretation. Our scientific expertise and regulatory insights enable us to provide valuable guidance in optimizing the development process, addressing regulatory requirements, and facilitating successful product commercialization.
- Training and Workshops: To empower pharmaceutical professionals and organizations, we conduct customized training sessions and workshops on various aspects of regulatory affairs, quality assurance, and drug development. These sessions provide practical insights, industry best practices, and updates on the latest regulatory guidelines, enabling attendees to enhance their knowledge and stay ahead in a dynamic regulatory landscape.
Whom we serve
API manufacturers, biopharmaceutical companies, CDMO
What you can expect
Improved confidence and effectiveness in your development programs and in your interaction with the regulatory agencies. Save time and money.
Useful information
Most frequently cited deficiencies in FDA warning letters and 483s
About Us
Experienced scientist and regulatory expert
Help you along every step of the product development process from product ideation to approval for all sizes of companies.
We speak Mandarin and English
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