Drug Regularly Affairs

Affordable for every hospital, clinic and medical practice to have the very best equipment, supplies and service.

Curensa Healthcare 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 Documents

Module 1 – Administrative Informations Common Technical Document
Module 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.

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.