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
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Regulatory Intelligence and Strategy

Services to provide our clients with valuable insights into Indian regulatory processes across various industries

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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

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Distribution and In-Licensing Assistance

Services to help our clients identify distributions partners and Channels, best suited for their businesses

Global Regulatory Services

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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.

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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.
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DMF (CTD format) Preparation, Review and Submission

Dossier Writing and Review

Dossier Registration: Submission to various regulatory agencies worldwide

Handling of query Responses

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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
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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
null

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
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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
null

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.

null

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.

null

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.
null

DMF (CTD format) Preparation, Review and Submission

Dossier Writing and Review

Dossier Registration: Submission to various regulatory agencies worldwide

Handling of query Responses

null

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
null

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
null

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
null

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
null

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

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Drug

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Food

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Cosmetic

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Medical Device

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Diagnostic Kit

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Biologicals

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Wireless Planning & Cordination

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Pesticide & Insecticide

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CRO

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Pythopharmaceutical Drug

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Regulatory Intelligence and Strategy

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Authorized Agent / Registration Holder Support

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Distributor Identification

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Distribution Point

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Strategy Planning

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Pre-Registration

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Registration

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Post-approval changes

India Regulatory Services
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Drug

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Food

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Cosmetic

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Medical Device

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Diagnostic Kit

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Biologicals

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Wireless Planning & Cordination

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Pesticide & Insecticide

null

CRO

null

Pythopharmaceutical Drug

Entry to the India Market
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Regulatory Intelligence and Strategy

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Authorized Agent / Registration Holder Support

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Distributor Identification

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Distribution Point

Global Regulatory Services
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Strategy Planning

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Pre-Registration

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Registration

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Post-approval changes

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