Pharma Regulatory Services

Drug Dossiers By Cyclone Pharma

Cyclone Pharmaceuticals Private Limited the Dossier consultant of India is having experience of writing more than 3000 different dossiers for different clients and different countries.

With writing of dossier we have developed many products and we have ready dossiers and technologies to launch for manufacturing with 100% validation support at your manufacturing unit.

When we write dossiers we assure perfect compilation and perfect review so that queries on documents shall be minimum.Our dossiers are surely get accepted by authority.

As per as Dossier and Drug master files are considered many authorities are also asking arises to our experts as we work on ground level and knows all difficulties while writing documents.

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL.

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation

The Common Technical Document (CTD)

The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, US) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Through ICH process, the CTD's guidance have been developed for Japan, European Union, and United States. Almost Most of the countries have adopted the CTD format. CTD is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States.

CTD Contains:The eCTD has five modules:

  1. Administrative information and prescribing information
  2. Common technical document summaries
  3. Quality
  4. Nonclinical study reports
  5. Clinical study reports

Many Small scale Manufacturers are confused with Dossier compilation and dossier writing,writing dossier is a technical skill and it involves study and review of technical documents of Client and compilation is just a document formating skill which can be handled by any non technical person.CPPL assures complete compliance of regulatory norms with its strong technical staff and knowledge gained throughout their industrial experience.

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL.

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation.

ASEAN Common Technical Dossier (ACTD)

This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use. This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements.

The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN CTD, a standard derived from the CTD. In place of the 5 modules, the ACTD organized the submission into 4 parts. This is done because ASEAN members usually only receive reference applications — applications to put a drug on the local market that has already been approved elsewhere. As a result, the need for detailed documentation is lessened — most study reports are not required to be submitted. Module 1 in the CTD (the regional and registration information) is still present as Part I in the ACTD. ICH M2 is dropped and the summaries are absorbed into the subsequence parts. Quality information (ICH M3) is Part II of the ACTD, Nonclinical (ICH M4) is Part III, and Clinical (ICH M5) is Part IV.

ACTD DOSSIER STRUCTURE

  • PART I : ADMINISTRATIVE INFORMATION
  • Part II : Quality
  • Part III: Nonclinical Study Reports
  • Part IV : Clinical Study Reports.

Cyclone Pharmaceuticals Pvt Limited is India's leading Regulatory consultant and involves in compilation of ACTD Dossiers with complete review of document.

In last 2 years we got expertise in compilation and filling of ACTD Dossiers in various asian countries.CPPL understands the practical issues and provides solutions to resolve the same.CPPL the dossier consultant are not only compiling dossiers but also involves in review and correction of documents.

With our experience of DRUG DOSSIER Compilation we observed that many documents of manufacturer are inadequate or it's having loopholes and if such documents are directly incorporated in dossier it is resulting in serious query and delays registration procedure,CPPL Team is believes compiling dossier is not a big task it's work of a computer operator but while compiling dossiers review of documents and suggesting appropriate corrections to minimizes queries is important and task of Technocrats,CPPL Regulatory team understands this and advise client on technical part of documents also and make your ACTD Dossier perfect for registration

eCTD Conversion and Submission is now more easy and affordable

What we Do:

  • We Write Dossier/DMF.
  • We Convert it in eCTD Format.
  • We Submit the same to Authority.

eCTD is now very much easy with eCTD Conversion software developed by India's leading regulatory consultant company CPPL

eCTD is not a rocket science it's regular Digital technology in PDF form which you have to submit instead of Paper Copy.

CPPL follow detailed procedure of conversion and submission of eCTD to different authorities through our newly developed software it will reduce down cost of submission to almost half the market cost.

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation

Drug Master file Service by CPPL

Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigation New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these. A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application. This guideline does not impose mandatory requirements (21 CFR 10.90(b)). It does, however, offer guidance on acceptable approaches to meeting regulatory requirements. Different approaches may be followed, but the applicant is encouraged to discuss significant variations in advance with FDA reviewers to preclude spending time and effort in preparing a submission that FDA may later determine to be unacceptable. Drug Master Files are provided for in 21 CFR 314.420. This guideline is intended to provide DMF holders with procedures acceptable to the agency for preparing and submitting a DMF. The guideline discusses types of DMF's, the information needed in each type, the format of submissions to a DMF, the administrative procedures governing review of DMF's, and the obligations of the DMF holder. DMF's are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file. When an applicant references its own material, the applicant should reference the information contained in its own IND, NDA, or ANDA directly rather than establishing a new DMF.

CPPL is having great experience in DMF Writing and is also authorized agent for US DMF submission and till now we have submitted more than 400 DMF to different authorities of the world

Many Small scale Manufacturers are confused with Dossier compilation and dossier writing,writing dossier is a technical skill and it involves study and review of technical documents of Client and compilation is just a document formating skill which can be handled by any non technical person.CPPL assures complete compliance of regulatory norms with its strong technical staff and knowledge gained throughout their industrial experience.

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL.

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation.

Drug Product Registration is easy now with Cyclone Pharmaceuticals Pvt Limited

Cyclone Pharmaceuticals Pvt Limited is providing Drug registration support services along with Dossier Compilation and dossier writing services for Asian,South African and other Countries

With our worldwide network we can able to provide support to Pharmaceutical manufacturers till the registration of their products in that country

Registration services by CPPL are with economy cost and it saves time as well.

Many Small scale Manufacturers are confused with Dossier compilation and dossier writing,writing dossier is a technical skill and it involves study and review of technical documents of Client and compilation is just a document formating skill which can be handled by any non technical person.CPPL assures complete compliance of regulatory norms with its strong technical staff and knowledge gained throughout their industrial experience

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation

Analytical Method Validation

AMV : Analytical Method Validation is most important part of any Dossier or DMF and our observation is that this part is being neglected by manufacturers many times and this leads to delay in registration of Pharmaceutical products.

CPPL suggests while compilation of DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format format of dossier manufacturers must concentrate on AMV (Analytical Method Validation Part ).We suggests appropriate way to go through the same and also provides services to perform analytical development and analytical method validation.

There is always confusion in minds of technocrats about need of AMV in dossier,many myths are there, but our technocrats in CPPL advises you about the technical input of AMV and saves your efforts as well as money.

Be careful about technical perfection of AMV there are many so called consultants who are giving you AMV in very low cost but they themselves do not know anything about Analytical Method validation,raise the question mark on the same and be careful while dealing with such consultants.

Requirement of Clinical Trials for Drug registration

Generic pharmaceutical products need to confirm to the same standards of quality,efficacy and safety as required of the originator’s (innovator) product. Specifically,the Generic product should be therapeutically equivalent and interchangeable with the reference product.Testing the bioequivalence between a test product pharmaceutically equivalent or a pharmaceutical alternative and a suitable reference product in a pharmaceutical study with a limited number of subjects is one way of demonstrating therapeutic equivalence. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical and clinical data to establish safety and effectiveness. This paper provides the information about important aspect involved in bioequivalence and Regulatory requirement for Bioequivalence study.

CPPL Team understands all requirements of Clinical and BA BE Study for different regulatory authorities hence is advising perfect solution in clinical sector also

Cyclone Pharmaceuticals Pvt Limited had audited and identified some CRO Centers which are having great expertise in this sector.Most advantageous point is CPPL team is having vigilance on the documents provided by service providers and it helps client for getting perfect documents.Document is reviewed and all the queries are being resolved from CRO and post submission queries will be minimized.

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL.

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation.

  • Comprehensive Bioequivalence Solutions.
  • Protocol design and development.
  • Phase I trial operation and management.
  • Data management.
  • Pharma co kinetic research.
  • Bioanalysis.
  • Statistical analysis,Report production.

Periodic Safety Update Report

A Periodic Safety Update Report (PSUR) is a pharmacological document intended to provide an update of the worldwide safety experience of a medicinal product to regulatory authorities at defined time points post-authorization.

The periodic safety update report for marketed drugs (PSUR) was designed to be a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. The PSUR can be an important source for the identification of new safety signals, a means of determining changes in the benefit-risk profile, an effective means of risk communication to regulatory authorities and an indicator for the need for risk management initiatives, as well as a tracking mechanism monitoring the effectiveness of such initiatives. For these reasons, the PSUR can be an important pharmacological tool. Numerous steps are involved in the PSUR process including: intake of adverse drug reaction information, case processing, data retrieval, data analysis, and medical review and risk assessment. These processes are heavily reliant on the availability of adequate resources. An overarching principle throughout the PSUR process is the need for a proactive approach in order to identify the critical steps in the process and to have a clear understanding of the consequences of any critical 'mis-step'. With this information comes appropriate planning, building quality into each step of the PSUR process and monitoring performance will maximize the likelihood of generating a quality report. Any failure of a key PSUR process will have the opposite effect - a poor quality report that will give little insight into emerging safety signals or provide misleading information that can adversely affect public health.

Every service provided by CPPL is adding some value to your organization .CPPL always concentrates on cost saving and always gives honest opinion on each requirement never suggests any impractical things which may lead to highest cost.CPPL Suggest only what's necessary and mandatory. Clients growth is our Growth.Clients success is always Consultants success. QUALITY COST TIME are three keys of success of Cyclone Pharmaceuticals Pvt Limited.

Many Small scale Manufacturers are confused with Dossier compilation and dossier writing,writing dossier is a technical skill and it involves study and review of technical documents of Client and compilation is just a document formating skill which can be handled by any non technical person.CPPL assures complete compliance of regulatory norms with its strong technical staff and knowledge gained throughout their industrial experience.

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL.

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation.

Query Support for Dossier and DMF

Post submission of dossier to any regulatory authority many queries are unanswered either because of lack of resources or because of not understanding the query by technical team.

With our experience CPPL learned that many queries are on analytical and process part specially on analytical method validation and Process validation part,here CPPL team can guide you with our expert teams knowledge.

CPPL have support of Analytical Service providers and process development labs for resolving different queries on product dossier.Knowledge of the technical concepts and cross linking of the documents is most important part and we have expertise to understand the same.

In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL.

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation.

Dossier Audit Service

Dossier writing is a skill and dossier reading is a Art …CPPL Team.Almost all pharmaceutical manufacturers are having their own regulatory affairs departments but it is not always necessary that regulatory professionals are having knowledge about process and also we observed that there is no strong coordination in QA and regulatory affairs department.

Dossier once written by Regulatory professional must be reviewed before submission to any authority . Small mistakes leads to a big loss or rejection of Dossier.

Example: In rush of document if by mistake wrong ingredient specification has been inserted by Regulatory professional in dossier you can not revert or recheck the same post submission. Another best example is audit of process documents like PDR shall match with manufacturing process, or specification shall match with unit formula etc etc. these are some examples of errors while writing dossiers.

In CPPL our technocrats takes care of review of dossier with their thorough knowledge of process and analytical documents and gives comments to your team for corrections.

Audit of Dossier is now a days necessary because if wrong dossier or inadequate dossier has been submitted it will lead to wastage of time and money, sometimes it may lead to rejection of dossier.To avoid this CPPL recommends audit of dossiers before submission so we can guide you at our best

Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation.

Dossier Audit is necessary :

  • To avoid future queries.
  • To save time and money.
  • To understand and evaluate functioning of your regulatory team.
  • To get perfection in Dossiers.

Why to Choose CPPL as your Regulatory and Dossier Partner:

  1. Knowledge of Pharmaceutical Technologies.
  2. Knowledge about formulation and analytical techniques.
  3. Minimizes time of registration with it's Perfect dossier service.
  4. Complete Support for Generating documents like PV,AMV,Stability.
  5. Comparatively very Low Cost (Do not compare with computer operators who provide Dossiers free of cost.
  6. Honest services ,we says yes if it is possible and no if having any difficulties.

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