Actd Dossier
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Product Specifications
| Format | ACTD |
| Sections | Four Parts |
| Content | Administrative, Quality, Non-clinical, Clinical |
| Compliance | ASEAN |
| Countries | Vietnam, Thailand, Singapore, Malaysia, Philippines |
| Usage | Pharmaceutical registration across ASEAN member states |
| Type | Dossier |
| Features | Regulatory Compliance, Time Savings, Resource Efficiency, Harmonized Format, Standard Elements |
Product Overview
Key Features
We are engaged in offering excellent quality ACTD Dossier in Mirzapur, Uttar Pradesh, India.
ACTD Format Dossier is also Described as ASEAN CTD Dossier, ASEAN Common Technical Dossier (ACTD) provides a common format for the preparation of well-structured Common Technical Dossier applications for submission in ASEAN regulatory authorities for the registration of pharmaceuticals for human use. ACTD format significantly reduce the time and resources needed to compile applications for registration. Regulatory reviews and communication with the applicant is facilitated by a standard document of common elements.
This guideline merely demonstrates an appropriate write-up format for acquired data. However,applicants can modify, if needed, to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results upon pharmaceutical registration.
Dossier writing and compilation as per ACTD Format.
Asian Common Technical Documents consists of following parts.
Part I a Administrative Data and Product Information
Part II a Quality Documents
Part III a Non Clinical Documents
Part IV a Clinical Documents.
ACTD Format is Asian harmonization for Common technical Documents used in Asian Countries like Vietnam, Thailand, Singapore, and Malaysia, Philippines & in Member States.
ACTD Format Dossier is also Described as ASEAN CTD Dossier, ASEAN Common Technical Dossier (ACTD) provides a common format for the preparation of well-structured Common Technical Dossier applications for submission in ASEAN regulatory authorities for the registration of pharmaceuticals for human use. ACTD format significantly reduce the time and resources needed to compile applications for registration. Regulatory reviews and communication with the applicant is facilitated by a standard document of common elements.
This guideline merely demonstrates an appropriate write-up format for acquired data. However,applicants can modify, if needed, to provide the best possible presentation of the technical information, in order to facilitate the understanding and evaluation of the results upon pharmaceutical registration.
Dossier writing and compilation as per ACTD Format.
Asian Common Technical Documents consists of following parts.
Part I a Administrative Data and Product Information
Part II a Quality Documents
Part III a Non Clinical Documents
Part IV a Clinical Documents.
ACTD Format is Asian harmonization for Common technical Documents used in Asian Countries like Vietnam, Thailand, Singapore, and Malaysia, Philippines & in Member States.
Company Details
Welcome to Sangam Global Pharmaceutical & Regulatory Consultancy (SGPRC) established in 2010, we are a group of Highly qualified professional having more than 10 years of vast experience in Pharmaceutical Regulatory Affairs, providing High quality Pharmaceutical Dossier Service to many Pharmaceutical companies. Our aim is to provide High Quality Pharmaceutical Dossier in all over the world.
Business Type
Service Provider
Employee Count
2
Establishment
2010
Working Days
Sunday To Sunday
Payment Mode
Cash in Advance (CID)
Certification
ISO 9001: 2015
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Seller Details
Mirzapur, Uttar Pradesh
Proprietor
Mr Sandeep Kumar
Address
Plot No-270/7 K, Angarh Road, Mirzapur, Uttar Pradesh, 231001, India
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