Regulatory Services

    regulatory

    DRUG REGULATORY AFFAIRS

    ACTIZA REGULATORY SERVICES

    CTD and eCTD submissions on all types of drug products, Packaging Materials
    Certificate of Suitability as per EP (CEP), Summary of Product Characteristics (SmPC)
    Periodic Safety Updates (PSUR), New Drug Application (NDA) , Investigational New Drug Application(IND) Abbreviated New Drug application (NDA)

    ACTD DOSSIERS

    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.

    Common Technical Document for ASEAN countries contains of four parts :-

    Part I : Administrative information
    Part II : Quality
    Part III : Nonclinical Study Reports
    Part IV : Clinical Study Reports

    NON-ACTD & CTD/ECTD

    Non-ACTD & CTD/eCTD Dossier (Country Specific)

    PharmaActdDossiers service are offering dossier as Non-ACTD & CTD/eCTD Dossier services as per country specific guideline. PharmaActdDossiers service offer a full report writing service. This service is offered where clients’ needs are closely matched to industry documentation conventions.

    Generation of All Documentation

    Stability reports compiled in accordance with CPMP-ICH preferred format which leads to ready incorporation into dossier submissions Compilation stability testing protocols, validation protocols & Validation reports Preparation of DCGI Files & COPP data. Dossier Preparation as per MOH requirement. We support till the receipt of Registration certificate. PharmaActdDossiers service offer time bound service with authenticate document.

    CTD - DOSSIERS

    Common Technical Document( Product Dossier) is an integral Part of any registration application for Marketing Authorization. Dossier in CTD Format/ ACTD Format or local country format is submitted to Food & Drug Authority or Ministry of health or any other equivalent authority along with other required technical documents and legal manufacturing permissions.

    Perfect Pharmaceutical Consultants can help you prepare entire technical document for drug product registration in various countries all over the world.

    PPC Provides following consulting service in regards to Technical Document

    Dossier Compilation and writing as per CTD Format – Common Technical Document
    Module 1 – Administrative Information
    Common Technical DocumentModule 2 - CT Overview
    Module 3 – Drug & Product Part /CMC
    Module 4 – Non Clinical
    Module 5 – Clinical

    CTD Format Dossier is widely used in semi regulated & regulated market like CIS Countries, Middle Eastern countries, European Union, USA , Australia , Canada, Japan, etc

    Dossier writing and compilation as per ACTD Format – Asian Common Technical Document

    Part I – Administrative Documents
    Part II – Quality Documents
    Part III – Non Clinical Documents
    Part IV – Clinical Documents.Pharma Consulting - Technical Document
    ACTD Format is Asian harmonization for Common Technical Document used in Asian Countries like Vietnam, Thailand, Singapore, and Malaysia etc

    We can help you compile and write entire technical document or specify modules as per your request, we also help companies establish their Document Management and technical writing system by guiding them with draft templates on BMR , COA , MOA , and other technical documents. We customize the same as per company requirement – Good for startup companies or scale up companies.

    Dossier Creation

    We write dossiers that meet all national and international requirements and is in accordance with all legal demands.

    Dossier in CTD (modules 1 – 5 or any requisite module) and eCTD formats for worldwide markets like EU, USA, UK,
    Preclinical and clinical Overviews / Summary writing based on literature search / Published studies / articles from journals .

    Dossiers for ASEAN and ROW countries in ACTD/ as per country specific format, for any dosage form.

    Dossier reformatting to CTD / eCTD by taking up gap analysis of existing dossiers in line with current requirements.

    Product information update (SmPC, PIL and Labeling).

    Preparation of Drug Master File and Certificate of suitability (open and closed part)
    Dossier review and maintenance
    Our counterparts in Europe take up review of dossiers prepared for registration in EU/UK.
    We will evaluate your technical data through all stages of the development process, review study protocols and conduct due diligence on your behalf.
    Provide EU-QP services for Pre-clinical and Clinical modules.
    Handling of all types of variations (Type Ia, Ib and II), annual reports, renewals of MAAs and support in query responses
    Translation services
    Translation of dossiers, SmPC, PIL, Packaging, Labeling & inserts, CRFs, clinical trial protocol & report etc to 60 + languages; viz European, Russian, ASEAN etc.
    Product Literature & Readability Testing
    SPC/SmPC, PIL and Labeling Texts

    We advise on the regulatory requirements for both content and format under legislation as well as write or review the relevant texts.

    Writing services for Summaries of Product Characteristics, Patient Information Leaflets and labeling texts. These documents can be created from scratch or existing texts can be updated to reflect changes in the registered details or to improve readability.

    Alternatively, we assess clients’ own product literature, and advise on the medical and scientific accuracy of the statements as well as checking for compliance with the registered details, the legal requirements, applicable guidelines and standard terms.

    Readability Testing

    Our counterparts in EU who have a panel of volunteers on whom the testing is carried out as per Article 59 (3) of Directive 2001/83/EC and customer specific requirements.

    Artwork Designing

    Our packaging design specialists will help you in the development of packaging to suit your individual product(s). From initial concept through production, we take charge of your packaging design project.
    Our creative packaging designers and production resources use years of design experience to provide you with superior service and value. Our team offers you package and display ideas that will grab the end users' attention and motivate them to buy your products.
    We provide a specialist service of precision driven artwork origination and print-ready files for any type of pharmaceutical primary and secondary packaging, which include the following:
    Folding boxes / cartons
    Patient information leaflets (PIL) / Information for users (IFU)

    Booklets
    Label
    Carton
    Blisters
    Tubes
    Sachets
    Adhesive labels
    Pouches and outserts
    Diagrams or illustrations
    Bespoke symbols or pictograms

    Medical Devices

    Our experienced packaging designer will support you in the packaging development. We can manage your entire artwork system, from creation through to post-licensing maintenance and packager liaison.

    Colour mock-ups of the leaflet and labels, meeting all the applicable guidelines and suitable for submission to regulatory authorities, can be provided

    Artwork is provided as PDF files suitable for electronic submission.

    GMP documentation

    Writing of QA, QC, Production, R&D and Corporate QA SOP’s
    Review and revision of existing SOP’s
    Audit to identify need for new SOP’s and prepare new SOP’s
    Preparation and review of packaging material and raw material specifications
    Preparation of quality manual and Policy for the company
    Preparation of Safety, health and environment related SOP’s
    Review existing MFR’s and revise to meet regulatory requirements
    Preparation of annual product review and trend analysis
    Preparation and revision of Site Master File
    Preparation and revision of Validation master Plan
    Review and revision of protocols for various types of validations
    Process Validation
    Analytical validation
    Cleaning validation
    Protocols for DQ, IQ, PQ and OQ for equipments
    Other GMP documents
    Review of documents and approvals from regulatory agencies to identify gaps and non compliances