1000+ DMF, AMVs, Dossiers, COAs available
100+ clients services around the world
20+ manufacturing sites
The field of regulatory affairs encompasses all the work that is necessary to receive and maintain a marketing authorization or registration for a medicinal product. Dossiers are at the forefront of this process. ICPC BIZ Regulatory Team works on behalf of pharmaceutical companies to compile information about medicinal products and present it in the form the authorities require. Clients have been placing their trust in ICPC BIZ expertise in preparing and maintaining such dossiers. ICPC BIZ compiles all information on clinical studies, medical safety and efficacy trials, medicinal product quality, analytical testing, approved use, pharmacovigilance and much more in an (electronic) common technical document, eCTD dossier.
ICPC BIZ carries out the maintenance of marketing authorization documents with the correct combination of accuracy and efficiency. Regulatory affairs specialists provide advice
ICPC BIZ takes over every aspect of maintaining and (re)formatting of existing documentation in eCTD or CTD format as needed. Apart from its vast experience in Regulatory ICPC BIZ unlocks its network to clients and connects you to state of the art pharmaceutical FDFs, API & excipient manufacturers worldwide. TABLETS, CAPSULES, LIQUID, INJECTABLES, SURGICALS, FOOD SUPPLEMENT
ICPCBIZ services include:
• Marketing authorization dossiers for human medicinal products (CTD modules 1 to 5)
• Marketing authorization dossiers for veterinary medicinal products
• Planning, preparing, updating and reformatting of quality dossiers
• Compilation of pharmacological/toxicological expert reports, clinical expert reports, environmental compatibility testing, etc.
• Communication with regulatory authorities
• Monitoring of deadlines
• Variations & Renewals
• Reformatting CTD > eCTD
• Supplying DMF, Drug master files, AMV Analytical Method Validation
• Pharmaceutical technology Transfer
Company Details
- Employees
- 2
- Founded
- -
- Address
- Ahmedabad, In
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- https://www.icpcbiz.com/
- Keywords
- ACTD Pharmaceuticals dossier, CTD Pharmaceuticals dossier, ECTD Pharmaceuticals dossier, Bioequivalence Study India, Pharmaceutical DMF, Drug Master File, Veterinary Product Dossier, Herbal Product Dossier, Food Supplement Dossier, pharmaceutical dossier, Pharma Liasoning, EU Dossier, Open Part DMF, Closed Part DMF, ROW Dossier, Product Registration, Regulatory affairs services.
- HQ
- Ahmedabad
Icpc Biz Questions
Icpc Biz's website is https://www.icpcbiz.com/
Icpc Biz's LinkedIn profile is https://in.linkedin.com/company/icpcbiz
Icpc Biz has
2 employees.
View email and phone details for 2
employees at Icpc Biz.
Icpc Biz's industry is
Business Consulting and Services
Icpc Biz's top competitors are
Stepup Pharmatech,
Missionpharma,
Vivanza Biosciences Ltd,
Orbit Pharmaceuticals,
Vitaa Global Bioscience Pvt. Ltd,
Tactus Lifesciences,
Isazi,
Neoplus Translation & Neocubes Pharma,
Vipro Lifescience,
S V Healthcare.
Icpc Biz's categories are Business Consulting and Services
Icpc Biz's founding year is 2012
