Global
Regulatory Service

No matter which country or region you wish to expand, CliniExperts can become your Regulatory Partner.

global-regulatory-service

Global Regulatory Service

We provide complete product life cycle management to our clients. Right from strategizing of products for specific markets, preparation and filing of appropriate documents to the Health Authorities of Regulated and Semi-regulated (Rest of the World- ROW) markets and post approval changes.We provide end to end support for all steps in your entry into the global markets.

Strategy Planning Services

Aligning client’s market (domestic or international) with its business goals and product needs in-depth research and preparation of blueprint for filing regulatory dossiers. Our detailed and comprehensive planning services ensure no snags at any level in your goal to product launch.

Strategy Planning Services

Assistance In

  • Selection of geographical regions for the Registrations of Dossiers in different markets (Semi-Regulated and Regulated) based upon the availability of the data.
  • Strategizing submission to developed countries, to reduce timelines for placement of products into export.

Assistance In

  • Selection of geographical regions for the Registrations of Dossiers in different markets (Semi-Regulated and Regulated) based upon the availability of the data.
  • Strategizing submission to developed countries, to reduce timelines for placement of products into export.

We provide advice management on the impact of current, newly finalized or proposed regulations, guidelines and standards and make recommendations accordingly.

We provide operational direction in Product Lifecycle Planning, facilitating registration of products.

The labeling regulations of a semi-regulated market may update frequently depending upon the revisions in regulations. Based on updated regulations know how, we help our clients efficiently modify the strategy for submissions. It enables them to obtain hassle-free and speedy approvals from the country’s health authorities.

We provide Periodic Safety Update Report (PSUR) solutions for export registration in various countries and regions i.e. US, EU, Africa, Latin America, CIS, ASEAN, GCC and others. Our skilled team can write and review Periodic Safety Update Report as per country specific guidelines as applicable.

Pre-registration Services

We offer data generation, regulatory and quality compliance services with gap analysis and expert reports in line with the regulations of the specific country facilitating successful registration.

Data Generation and Data Review for Drug Substance and Drug Product DMF

We assist our clients in development of new products and data generation in line with country specific registration guidelines/regulations.

We provide guidance in development and preparation of R&D documents like AMV Protocols and Reports, Stability Protocols and Reports, Product Development Report (PDR) in CTD (ASEAN, EU or ICH) format.

We assist our clients in designing Comparative Dissolution Studies (with IVIVC) and in generating an acceptable data report for submission in the Health Authority. The summary of comparative studies of the product is required in the module 3.2.P.1 along with cross reference to the studies (with study numbers). It links the clinical formulations to the proposed commercial formulation and a successful correlation can assist in the selection of appropriate dissolution acceptance criteria.

We have collaboration with certified labs for analytical method development, method validation and transfer services. These labs are capable of performing validation as per ICH guidelines, acceptable to MOH/FDA of ASEAN, African, CIS, Latin American and Rest of World (ROW). We handle the queries from MOH/FDA related to validation well. As your research partner, we provide detailed protocol, chromatograms and report for method development and validation at the conclusion of each Validation project which is acceptable at MOH/FDA during product registration.

We assist our clients in planning their BA/BE studies, obtaining NOC for BE from the intended country of export, and in conducting Bioequivalence (BE) and Bioavailability (BA) Studies with well-known CROs.

We assist our clients in selection and identification of suitable Comparator/Reference Listed Drug product for the Generic applicants. Also, our team supervises and enables procurement/ import of Innovator Products required for the Comparative studies that helps in the generation of development data required for Dossier Registrations with MOH/FDA.

Regulatory & Quality Compliance Services & Expert Reports

At CliniExperts, our compliance consultants have a strong working knowledge of requirements and can help implement the necessary quality systems to meet the regulations. Additionally, we have substantial experience helping clients with remediation when their quality systems implementation and management fall short of meeting regulatory requirements.

We offer due diligence services for existing dossier and technical data for the dossier preparation as per the country specific requirements. We assist our clients in preparing the documents, using the regulatory compliant formats and closely monitor each step while working with them to fill the gaps for better Regulatory & Quality compliance. This minimizesthe queries raised during dossier assessment during GMP inspection by Country Health Authorities/MOH.

GMP site inspection is one of the mandates for issuing of Registration Certificate by any Health Authority. We provide GMP consulting to proactively help our clients avoid issues with regulatory agencies enabling smooth registration process.

At CliniExperts, a detailed analysis is done of all the documents received from our clients. The loop holes observed as per country specific requirements are filled for strengthening the dossiers for better compliance. This enables them get speedy approvals.

Our team also ensures the conversion of dossiers to country specific requirements and from CTD to ACTD format or vice versa and verified for compliance.

We provide guidance & assistance by working closely with the technical team of clients towards the generation of adequate data for successful submission of the dossier to Country specific MOH/Health authorities.

Registration

We provide regulatory solutions for International Dossier Registration in geographical regions worldwide providing support for DMF (CTD format) Preparation, Review and Submission, preparation of administrative documents, technical documents and dossier registration and handling query responses.

DMF (CTD format) Preparation, Review and Submission

Our dedicated technical team of experts writes and reviews DMF/CTD as per ICH CTD/ASEAN CTD/Country specific guidelines. We also assist in the publishing and submission of USDMF and eDMF to USFDA. We assist our clients during the Product Registration till approval and also provide the support to address the MOH queries received for their other associated applicants, if needed.

Administrative Documents

We guide our clients on know-how about the kind of documents required for specific country registration. Along with we assist them to draft and finalize the country specific administrative documents/CTD Module-1. This includes (though, not limited to)- Letter of Authorization, Pack insert / PIL/Summary of Product labeling (SmPC/SPC), preparation of label and carton contents, justification for FDC, Global Patent Information, Literature for patented product and other administrative documents.

Technical Documentation (Writing and Review)

We assist our clients in preparation of USDMF/EDMF in CTD format, writing Quality Overall summary (QOS), and manufacturing and characterization part of DMF. We provide support in preparing documents for process validation, AMV and Stability Studies, Specifications, Method of Analysis (MOA) and Certificate of Analysis (COA) of Raw materials and API. We also assist them in query response to MOH/FDA.

Dossier Registration: Submission to various regulatory agencies worldwide

CliniExperts is a one stop for Global Regulatory Solutions which assists clients in seamless entry into Global regions by getting their products registered as per the expected timelines with minimal anticipated queries with Get –it-Right-at-first time approach. Support in full dossier writing as well as review of documents is done for companies interested in Pharma Export Business. We prepare, write, review the dossiers (as required) as per European/US CTD and ASEAN CTD and non-CTD/country-specific requirements and finally submit to respective Health Authorities.

Handling of Query Responses

We provide assistance in review and timely query response to the Regulatory Agencies/Health Authorities. A detailed discussion, planning and follow-up with the clients is done for the generation of additional data as required.

Post Approval Changes

We provide regulatory assistance in Post-Approval Changes/Variation (minor, major, critical), assisting our clients to upgrade the existing products with additional data generation to the requirements of the countries. This includes planning, preparation and submission of the additional documents.

Providing regulatory intelligence and guidelines regarding updates pertaining to regulatory changes, timelines, and required data in the existing product dossiers of the clients.

Assistance in extension of labels and shelf life is also provided.

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