DRUG REGULATORY AFFAIRS
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)
The ASEAN (Association of Southeastern Asian Nations) has observed this and is 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 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.
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 offering dossier as Non-ACTD & CTD/eCTD Dossier services as per country-specific guidelines. PharmaActdDossiers service offers 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 you till the receipt of the Registration certificate. PharmaActdDossiers service offers time-bound service with authenticated documents.
CTD – DOSSIERS
Common Technical Document( Product Dossier) is an integral part of any registration application for Marketing Authorization. A dossier in CTD Format/ ACTD Format or local country format is submitted to the 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 documents for drug product registration in various countries worldwide. PPC Provides the following consulting service in regard to Technical Document Dossier Compilation and writing as per CTD Format – Common Technical Document
Module 1 – Administrative Information 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 markets 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 Documents used in Asian Countries like Vietnam, Thailand, Singapore, Malaysia, etc
We can help you compile and write an entire technical document or specify modules as you requested, 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 requirements – Good for startup companies or scale-up companies.
- 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 the 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 a review of dossiers prepared for registration in the 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 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 the 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.
Our counterparts in the EU 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.
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)
- Adhesive labels
- Pouches and outserts
- Diagrams or illustrations
- Bespoke symbols or pictograms
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.
- Writing of QA, QC, Production, R&D, and Corporate QA SOPs
- Review and revision of existing SOPs
- Audit to identify the need for new SOPs and prepare new SOPs
- 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 SOPs
- Review existing MFRs and revise them to meet regulatory requirements
- Preparation of annual product review and trend analysis
- Preparation and revision of Site Master File
- Preparation and revision of the 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 equipment
- Other GMP documents
Review of documents and approvals from regulatory agencies to identify gaps and noncompliances