- Introduction
To be sold in a market or region, pharmaceuticals and other medical products must be registered with the regulatory bodies of that market or region. For the review and evaluation of pharmaceuticals, each market or region has its own unique set of criteria and forms. Implementing permission requirements and procedures without any errors is challenging for regulatory departments and companies because every framework is different.This results in an extension of the timetable for the procedures related to assessing a new product. The numerous standards and regulations from international organizations like the WHO and ICH, as well as the restrictions set by certain nations or areas, can also prolong the processes. As a result, there are many different regulatory standards and processes in different nations for new product marketing authorizations.
It is an extensive and complex procedure to comprehend these various regulations and build a plan that follows the guidelines set by international agencies like the WHO and ICH. Technical data reviews prior to submission, gap analysis, regulatory content writing, dossier validation, compilation, and electronic publication of new product authorization applications for worldwide filing are all services we provide. Additionally, we provide comprehensive consulting services for New Product Authorization and practical assistance to pharmaceutical companies.
We provide End-to-end regulatory services which compile, publish and manages IND (Investigational New Drug), NDA (New Drug Application), ANDA (Abbreviated New Drug Application), DMFs (Drug Master Files), ASMF (Active substance master file procedure), CEP and also BLAs (Biologic License Applications) dossiers for global regulatory authority such as USFDA Agent Services, EMA, MHRA, GCC, Health Canada, SAHPRA, JFDA, AUTGA, SWISSMEDIC.
- eCTD Dossier Publishing & Compilation
- Dosser QC Review and Submission
- ACTD, CTD, and NeeS submission
- Technical Validation of received documents
- DMF publishing from type I to IV
- Query response and management
- Bookmarking and Hyperlinking as per the validation criteria
- Document Formatting – Word Style Guides and PDF Navigation
- Conversion of NeeS or paper dossiers to eCTD for Baseline submissions
- Easily add new supplementals and amendments to existing Dossier application
- Compile file consolidated Dossier with all supplements and amendments into a single document
- Review of quality documents like Specifications, Analytical Methods, Validation Report and Stability Data, Batch Records.
- Preparation and review Reports of information required for the development of regulatory CMC
Service Available For...
USFDA
Submission as per USFDA Latest Validation Criteria
- Type-II DMF – API, Intermediate and semi-finished formulation
- Type-III DMF – Packaging
- Type-IV DMF – Excipients
- Post approval changes (CBE0, CBE30, PAS)
- Pre IND meetings and submission
- STF (Study Tagging File) per STF version 2.6.1
- Annual updates
- Request to information
- Periodic Adverse Drug Experience Report (PADERS)
EU
Submission as per EU Latest Validation Criteria
- Submission for National (NP), Decentralise (DCP), Centralise (CP) and Mutual recognition (MRP)
- Tracking Table Generation
- Wave submission
- Variations Type – I (Type-IAIN, Type-IA, Type-IB) and Type – II
- Renewal
- Marketing Authorisation Transfer (MAT)
- EDQM Submission
- PSUR Publishing
- Clinical Trial Application (CTA)
HEALTH CANADA
Submission as per HC Latest Validation Criteria
- New Drug Submission (NDS)
- Supplement to New Drug Submission (SNDS)
- Supplement to New Drug Submission – Confirmatory(SNDS-C)
- Abbreviated New Drug Submission (ANDS)
- Supplement to Abbreviated New Drug Submission (SANDS)
- Veterinary drugs (Division 1 and 8)
GCC
Submission as per GCC Latest Validation Criteria
- New Market Authorization (MA)
- Renewals of MA
- Variation Type 1 & Type 2
- Responses to Questions
- Risk Management Plan
- Periodic Safety Update Report (PSUR)
MCCZA (SAHPRA)
Submission as per MCCZA Latest Validation Criteria
- New Chemical Entity – Pharmaceutical Biological, Multisource, Biosimilar, Line extension, Call-up, Complementary and Alternative Medicines
- Inspectorate, Clinical, Proprietary name change application, Applicant transfer, Complementary and Alternative Medicine
- Scheduling, Response to Council resolutions
SWISSMEDIC
Submission as per Swissmedic Latest Validation Criteria
- New Market Authorization
- Renewals
- Variation Type 1 & Type 2
- Responses to Questions
- ASMF
THAILAND
Submission as per Thai FDA Latest Validation Criteria
- Initials Submission
- Amendments
AUTGA
Submission as per AUTGA Latest Validation Criteria
- Market Authorization Application (MAA)
- Amendments
JORDAN
Submission as per JFDA Latest Validation Criteria
- Baseline Submissions
- Initial Market Authorization
- Amendments
EU VNEES
Submission as per the Latest Validation Criteria
- Biological
- Immunological
- Pharmaceutical
- MRL
To be sold in a market or region, pharmaceuticals and other medical products must be registered with the regulatory bodies of that market or region. For the review and evaluation of pharmaceuticals, each market or region has its own unique set of criteria and forms. Implementing permission requirements and procedures without any errors is challenging for regulatory departments and companies because every framework is different.
This results in an extension of the timetable for the procedures related to assessing a new product. The numerous standards and regulations from international organizations like the WHO and ICH, as well as the restrictions set by certain nations or areas, can also prolong the processes. As a result, there are many different regulatory standards and processes in different nations for new product marketing authorizations. It is an extensive and complex procedure to comprehend these various regulations and build a plan that follows the guidelines set by international agencies like the WHO and ICH.
Technical data reviews prior to submission, gap analysis, regulatory content writing, dossier validation, compilation, and electronic publication of new product authorization applications for worldwide filing are all services we provide. Additionally, we provide comprehensive consulting services for New Product Authorization and practical assistance to pharmaceutical companies.
We provide End-to-end regulatory services which compile, publish and manages IND (Investigational New Drug), NDA (New Drug Application), ANDA (Abbreviated New Drug Application), DMFs (Drug Master Files), ASMF (Active substance master file procedure), CEP and also BLAs (Biologic License Applications) dossiers for global regulatory authority such as USFDA Agent Services, EMA, MHRA, GCC, Health Canada, SAHPRA, JFDA, AUTGA, SWISSMEDIC.
- eCTD Dossier Publishing & Compilation
- Dosser QC Review and Submission
- ACTD, CTD, and NeeS submission
- Technical Validation of received documents
- DMF publishing from type I to IV
- Query response and management
- Bookmarking and Hyperlinking as per the validation criteria
- Document Formatting – Word Style Guides and PDF Navigation
- Conversion of NeeS or paper dossiers to eCTD for Baseline submissions
- Easily add new supplementals and amendments to existing Dossier application
- Compile file consolidated Dossier with all supplements and amendments into a single document
- Review of quality documents like Specifications, Analytical Methods, Validation Report and Stability Data, Batch Records.
- Preparation and review Reports of information required for the development of regulatory CMC
