About me, Jessica Mu: With 28 years of experience in the life sciences quality and compliance space, including over 20 years at the U.S. Food and Drug Administration in Investigations, Compliance Officer, and Compliance Director roles, and nearly a decade in industry, I’ve navigated the medical device product lifecycle from both sides of the fence. […]
NPDK Bioconsulting is a Regulatory CMC consulting and regulatory writing firm specializing in the development, compliance, and FDA regulatory support for a broad range of biotechnology and biopharmaceutical products, including cell and gene therapies (CAR-NK, CAR-T, viral vector-based), monoclonal antibodies, antibody-drug conjugates (ADCs), therapeutic proteins, vaccines, and any new therapeutic modalities. We also offer intellectual […]
MDSS: Your trusted partner for In-Country Representation & comprehensive regulatory support! For over 30 years, MDSS (mdssar.com) has been a trusted Authorized Representative specializing in Regulatory Affairs for Medical and In Vitro Diagnostics devices. We offer comprehensive In-Country Representation across the EU, UK, Switzerland, USA, and Australia, designed to minimize complexity, save time, and reduce […]
EnGenius Solutions is a boutique consulting firm that offers Quality Management Systems consulting. EnGenius Solutions is differentiated by its unique expertise on medical device software (SaMD, SiMD, AIMD, MLMD) as well as its commitment to effective and efficient quality systems as captured by its non-BS manifesto. EnGenius Solutions offers the services mentioned below. You can […]
Email: deborah@madsenqrc.com Phone/text: 909-720-9071 Madsen QRC provides quality system and regulatory compliance consulting to the medical device device industry. Areas of expertise include: Providing advice, assistance and guidance to the medical device industry in the areas of quality systems, ISO 13485, FDA QMSR, IEC 62304, and MDSAP implementation and compliance. Internal and supplier audits in […]
Qualomics specializes in start-ups and small businesses that need fractional Quality Management services. We offer SOP templates, authoring and revisions, quality planning, training, validations, auditing, and quality operations. Contact Qualomics to learn more.
At Kim Walker Consulting (www.kimwalkerconsulting.com), we provide our clients tailor-made support with global regulatory, quality system, and clinical requirements. We offer guidance and know-how to optimize the time to market for your products. We provide Total Product Lifecycle regulatory support, design control support, clinical trial design, GCP compliance and audit capabilities, pre-market submissions, quality system […]
Contact: Louie Goryoka, ISO Certified Lead Auditor, CQE, MBA – Sr. Consultant Med-Device Consulting, Inc. is a quality/regulatory consultancy organization in U.S. FDA and International quality and regulatory affairs compliance programs for the medical device, IVD, Cosmetic and personal lubricant Manufacturer, and Nutraceutical / Food / Dietary Supplements. Service and Expertise include: Emergency Use Authorization […]
