Mask And Gloves
All Essential Medical Supplies For Frontline Healthcare Professionals Needed To Fight The COVID 19 Pandemic Like Masks And Gloves Are Available With Us For Bulk Orders
Masks and gloves of all varieties available for distributors, agents and representatives.
About Us
CliniExperts, a leading regulatory service provider, has now established operations in Singapore.
The new office acts as their headquarters to provide Healthcare Regulatory Affairs, Entry to Market, and Distributor Identification services to clients across South Asia.
This makes them the only India-based company that provides comprehensive regulatory and licensing consultancy services to businesses in the life sciences industry, the world over.
We offer critical services to our Global Clients
Services that enable seamless entry to the India market
Regulatory Intelligence and Strategy
Services to provide our clients with valuable insights into Indian regulatory processes across various industries
Authorized agent/Registration Holder Support
Services to assist foreign companies with no presence in India acquire their licensing and registration by acting as their in-country regulatory representatives
Distribution and In-Licensing Assistance
Services to help our clients identify distributions partners and Channels, best suited for their businesses
Global Regulatory Services
The CliniExperts team puts together a time tested regulatory strategy, customized to your specific requirement that identifies and mitigates potential challenges in order to obtain approval for EU, USA and Emerging Markets. The team defines Clinical Non-clinical and Technical requirements and helps in developing a quality product dossier.
Data Generation and Data Review w.r.t Drug Substance and Drug Product DMF
- Development & Preparation of R&D documents
- Dissolution Comparative Studies Designing and Data Report
- AM development and Validation as per ICH Q2A, Q2 BA/BE studies
- Reference Listed Drug (RLD)/Innovator Product/Comparator
Regulatory & Quality Compliance Services & Expert Reports
- GMP Audits/Site Due Diligence- API Site, FP Sites, Manufacturing Sites
- Dissolution Comparative Studies Designing and Data Report
- Gap analysis on the Existing documents/data/dossier and conversion to country specific/ACTD to CTD and vice versa
- Guidance & assistance on generation of data for successful submission of the Dossier to Country MOH/Health authorities.
DMF (CTD format) Preparation, Review and Submission
Dossier Writing and Review
Dossier Registration: Submission to various regulatory agencies worldwide
Handling of query Responses
CliniExperts provides post-approval services which include carrying out product re-registration is well ahead of time. Renewal of Site GNP is also carried out according to schedule. Services also include renewal of BE center GCP certification and submission of Annual Product Review Submission to the concerned health authority.
-
Strategy
Planning -
The CliniExperts team puts together a time tested regulatory strategy, customized to your specific requirement that identifies and mitigates potential challenges in order to obtain approval for EU, USA and Emerging Markets. The team defines Clinical Non-clinical and Technical requirements and helps in developing a quality product dossier.
-
Pre
Registration -
Data Generation and Data Review w.r.t Drug Substance and Drug Product DMF
- Development & Preparation of R&D documents
- Dissolution Comparative Studies Designing and Data Report
- AM development and Validation as per ICH Q2A, Q2 BA/BE studies
- Reference Listed Drug (RLD)/Innovator Product/Comparator
Regulatory & Quality Compliance Services & Expert Reports
- GMP Audits/Site Due Diligence- API Site, FP Sites, Manufacturing Sites
- Dissolution Comparative Studies Designing and Data Report
- Gap analysis on the Existing documents/data/dossier and conversion to country specific/ACTD to CTD and vice versa
- Guidance & assistance on generation of data for successful submission of the Dossier to Country MOH/Health authorities.
- Registration
-
DMF (CTD format) Preparation, Review and Submission
Dossier Writing and Review
Dossier Registration: Submission to various regulatory agencies worldwide
Handling of query Responses
-
Post Approval
Changes -
CliniExperts provides post-approval services which include carrying out product re-registration is well ahead of time. Renewal of Site GNP is also carried out according to schedule. Services also include renewal of BE center GCP certification and submission of Annual Product Review Submission to the concerned health authority.
The CliniExperts team puts together a time tested regulatory strategy, customized to your specific requirement that identifies and mitigates potential challenges in order to obtain approval for EU, USA and Emerging Markets. The team defines Clinical Non-clinical and Technical requirements and helps in developing a quality product dossier.
Data Generation and Data Review w.r.t Drug Substance and Drug Product DMF
- Development & Preparation of R&D documents
- Dissolution Comparative Studies Designing and Data Report
- AM development and Validation as per ICH Q2A, Q2 BA/BE studies
- Reference Listed Drug (RLD)/Innovator Product/Comparator
Regulatory & Quality Compliance Services & Expert Reports
- GMP Audits/Site Due Diligence- API Site, FP Sites, Manufacturing Sites
- Dissolution Comparative Studies Designing and Data Report
- Gap analysis on the Existing documents/data/dossier and conversion to country specific/ACTD to CTD and vice versa
- Guidance & assistance on generation of data for successful submission of the Dossier to Country MOH/Health authorities.
DMF (CTD format) Preparation, Review and Submission
Dossier Writing and Review
Dossier Registration: Submission to various regulatory agencies worldwide
Handling of query Responses
CliniExperts provides post-approval services which include carrying out product re-registration is well ahead of time. Renewal of Site GNP is also carried out according to schedule. Services also include renewal of BE center GCP certification and submission of Annual Product Review Submission to the concerned health authority.
-
Strategy
Planning -
The CliniExperts team puts together a time tested regulatory strategy, customized to your specific requirement that identifies and mitigates potential challenges in order to obtain approval for EU, USA and Emerging Markets. The team defines Clinical Non-clinical and Technical requirements and helps in developing a quality product dossier.
-
Pre
Registration -
Data Generation and Data Review w.r.t Drug Substance and Drug Product DMF
- Development & Preparation of R&D documents
- Dissolution Comparative Studies Designing and Data Report
- AM development and Validation as per ICH Q2A, Q2 BA/BE studies
- Reference Listed Drug (RLD)/Innovator Product/Comparator
Regulatory & Quality Compliance Services & Expert Reports
- GMP Audits/Site Due Diligence- API Site, FP Sites, Manufacturing Sites
- Dissolution Comparative Studies Designing and Data Report
- Gap analysis on the Existing documents/data/dossier and conversion to country specific/ACTD to CTD and vice versa
- Guidance & assistance on generation of data for successful submission of the Dossier to Country MOH/Health authorities.
- Registration
-
DMF (CTD format) Preparation, Review and Submission
Dossier Writing and Review
Dossier Registration: Submission to various regulatory agencies worldwide
Handling of query Responses
-
Post Approval
Changes -
CliniExperts provides post-approval services which include carrying out product re-registration is well ahead of time. Renewal of Site GNP is also carried out according to schedule. Services also include renewal of BE center GCP certification and submission of Annual Product Review Submission to the concerned health authority.
Complete Gamut of Services We Offer
Drug
Food
Cosmetic
Medical Device
Diagnostic Kit
Biologicals
Wireless Planning & Cordination
Pesticide & Insecticide
CRO
Pythopharmaceutical Drug
Regulatory Intelligence and Strategy
Authorized Agent / Registration Holder Support
Distributor Identification
Distribution Point
Strategy Planning
Pre-Registration
Registration
Post-approval changes
- India Regulatory Services
-
Drug
Food
Cosmetic
Medical Device
Diagnostic Kit
Biologicals
Wireless Planning & Cordination
Pesticide & Insecticide
CRO
Pythopharmaceutical Drug
- Entry to the India Market
-
Regulatory Intelligence and Strategy
Authorized Agent / Registration Holder Support
Distributor Identification
Distribution Point
- Global Regulatory Services
-
Strategy Planning
Pre-Registration
Registration
Post-approval changes
Reach Us
Use the info below to contact us or give us a visit to chat over a cup of Coffee.
- #10 Anson Road
#11-20 International Plaza
Singapore- 079903 - +65 69515401
- contact@cliniexperts-asia.com