Specializing in helping small to mid-sized domestic and international companies with the preparation of all necessary regulatory documentation to bring their FDA regulated products to market.
Working on regulatory submissions and designing regulatory strategies on a broad spectrum of regulated products.
Focused on the CMC part of the regulatory dossier, including Manufacturing and Design Control documentation, Product Composition, Design and Specifications, Environmental Assessment, Stability Studies, Control Strategies, etc. Working with a variety of technical documentation related to the development, manufacture, and testing of various complex products, conducting independent research as needed to enable the writing of summary sections for regulatory submissions.
Drafting, reviewing, editing, and compiling submission documents and providing regulatory input into change controls, CAPAs, NCRs; assessment of the regulatory impact of changes in product specifications, manufacturing process, labeling to ensure compliance with FDA and international government requirements, including compliance with cGMP.
Specializing in product development support for medical device and diagnostic companies consistent with ISO 13485 and 21CFR820, manufacturing, assembly, packaging and testing services; analytical methodology validations/verifications (ICH Guidelines) and process validation protocols and reports.
Supporting audits/inspections to ensure full compliance for US audits/inspections of external manufacturing sites.
Company Details
- Employees
- 1
- Address
- Grand Rapids, Mi, Us
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- http://ntcmcconsulting.com/
- Keywords
- Richmond.
- HQ
- Grand Rapids, MI
Nt Cmc Regulatory Consulting Questions
Nt Cmc Regulatory Consulting's website is http://ntcmcconsulting.com/
Nt Cmc Regulatory Consulting's LinkedIn profile is https://www.linkedin.com/company/nt-cmc-regulatory-consulting
Nt Cmc Regulatory Consulting has
1 employees.
View email and phone details for 1
employees at Nt Cmc Regulatory Consulting.
Nt Cmc Regulatory Consulting's industry is
Pharmaceutical Manufacturing
Nt Cmc Regulatory Consulting's top competitors are
Accorto Regulatory Solutions,
Ptc Therapeutics, Inc.,
Cs Lifesciences,
Sibionics,
Abingdon Health Plc,
Fivepharma,
Corium,
Dlrc Regulatory Consultancy,
European Regulatory Affairs Limited (Formerly Ivowen),
Transcrip.
Nt Cmc Regulatory Consulting's categories are Pharmaceutical Manufacturing
