#ectd format

[freyrsolutions]

Freyr SUBMIT Pro is one of the best eCTD software tool which helps Life science companies in various regulatory submissions to global health Authorities.

[willingjet]

Life Science Solutions

Life Science Translation

Willingjet provides premium translation services for pharmaceutical, biotech, and medical device companies and CROs with high-quality.  

We have provided language solutions to the life science industry for more than two decades, our professional experts and native-speaking translators have more than ten years of experience, covering more than 100 languages. Willingjet has aquired ISO 17100 , ISO 9001:2015 and ISO 13485:2016 certifications to guarantee our medical translation services complying with the stringent regulatory requirements worldwide.

Medical translation document types

Documents included in drug registration dossier:

M2: Quality summary, non-clinical review and summary, clinical review and summary, etc.;

M3: Manufacturing information, specification, analytical methods and validation, stability study, container closure system for drug substance and drug product;

M4: Pharmacology, pharmocodynamic, pharmacokinetic, toxicology research reports, etc.;

M5: Clinical study protocol, clinical study report, investigator brochure, ccds, package insert, etc.

Documents from the medical device company:

Patient Information

Patient Reported Outcomes (PROs)

Medical device safety and pharmacovigilance document

Clinical trial protocol

Product labeling and packaging

Documents submitted to regulatory agencies

Instructions for use

Technical manual

Medical literature

Medical equipment instructions and installation manuals

Marketing and advertising

Websites, software, mobile apps and IoT

Online learning and training

Legal, financial documents

Documents from the medical device company:

Documents from CROs:

Managing Multi-regional clinical trial in many languages

Clinical trial documents

Patient engagement and recruitment

Contracts and POs

Registration dossier

Contact Us

Professional DTP

We have self-developed DTP software and are good at using industry-standard desktop typesetting and editing tools, including the eCTD format of drug/medical device registration dossier, user manuals, technical documents, and software GUI layout. Our DTP experts have professional knowledge of specific language environments and can produce high-standard dtp design service for any language product.

[aquilasolutions]

Data Security and Confidentiality in eCTD Publishing Tools: Safeguarding Sensitive Information

In the current era of digitalization life sciences has seen a major change in the way that regulatory submissions are developed and presented. Electronic Common Technical Document (eCTD) publishing has transformed the process of submission by making it faster and more efficient. However, with the ease that digital technologies offer comes the vital responsibility of ensuring security and privacy.

This article will dive into the crucial role of security for data in eCTD publishing and discuss methods to safeguard sensitive information during the entire submission process.

The Imperative of Data Security

Security of data isn't an unimportant checkbox on the list of regulatory compliance. The eCTD Software format permits biotech and pharmaceutical companies to prepare electronic submissions of their application that has numerous advantages like a reduction in paper use speedier reviews and improved collaboration. However, it also presents risks if not managed properly.

• Protection of intellectual Property: Pharmaceutical companies invest large amounts of money for developing and research. Data security is essential to prevent unauthorised access to confidential information, thereby protecting intellectual property rights of the company.

• Patient Privacy: Data from clinical trials and patient information should be handled with utmost security to ensure privacy for patients and to comply with laws on protection of data.

• Regulation Compliance: A lot of regulatory eCTD Submission Software agencies require a strict adherence to standards regarding data security in their submission specifications. Failure to adhere to these standards can lead to delays or even rejections.

• Reputation and Trust: Keeping secure and confidential data builds trust with regulators and partners as well as others. Any breach could damage the image of a company irreparably.

Strategies for Safeguarding Sensitive Information

• Secure encryption: Use strong encryption methods to safeguard the data during transport and in rest. By using encryption, even in the event of unauthorized access the data is unreadable and inaccessible.

• Access Controls: Set strict access control that restricts the access of users to view or edit sensitive information. Multi-factor authentication adds a new layer of protection to the user's access.

• Audit Trails: Keep precise audit trails that record every step performed inside the eCTD publishing system. This does not just increase accountability, but also assists in identifying any suspicious actions.

• Secure Infrastructure: Select eCTD publishing tools built on secured infrastructure, frequently updated to fix security holes and are armed with intrusion prevention systems and firewalls.

• Users Training: Offer extensive training for employees who are engaged within participating in the eCTD publishing procedure. Be sure that they are aware the security protocols and best practices for avoiding unintentional breach.

• Data Minimization: Only include the information required in submissions, thus reducing the chance of disclosing sensitive information. This improves the efficiency of the process of reviewing.

• Vendor Due Diligence: When you are using an external third party eCTD software for publishing, perform thorough due diligence regarding the security measures they use and their certifications.

• Periodic Audits and Evaluations: Perform periodic security assessments and audits in order to discover vulnerabilities and then take action to address these.

The Final Thought!!

The life sciences industry continues to adopt eCTD Publishing Tools for submissions to regulatory agencies and submissions, the need to secure sensitive data has never been more important. Data breaches can result in a variety of implications, from regulatory repercussions and irreparable harm to a business's reputation.

When they prioritize the security and confidentiality of data pharmaceutical and biotech companies will be able to traverse the cyber world with confidence, build trust with regulatory agencies as well as others, and guarantee the continuous success of their data submissions.

[sudheervanguri]

Torrent Pharma Walk-in Drive: Unleash Your Potential in Pharmaceutical Innovation Torrent Pharmaceuticals, a leading name in the pharmaceutical industry committed to pioneering healthcare solutions. With a focus on research and development, Torrent Pharma has been at the forefront of bringing innovative and high-quality pharmaceuticals to the market. Company Vacancies List 1. Regulatory Affairs Department Position: Assistant Manager Experience: 9-12 years Qualification: M. Pharm/ M.Sc. Job Description: Compilation and review of registration dossiers as per country-specific guidelines. Preparation of dossiers in eCTD format for ANDA, EU-MA application. Dossiers for Emerging markets. Dossier applications for the Brazil market. Application for manufacturing and marketing in India. Life cycle management of ANDA, EU-Application, and for emerging markets. Experience in API DMF filing. Candidates with experience in solid orals and/or topicals are preferred. Position: Executive Experience: 2-8 years Qualification: M. Pharm/ M.Sc. Job Description: Dossiers for Emerging markets. Dossier applications for the Brazil market. Application for manufacturing and marketing in India. Life cycle management of ANDA, EU-Application, and for emerging markets. Experience in API DMF filing. Candidates with experience in solid orals and/or topicals are preferred. 2. Analytical Development Laboratory Position: Executive Experience: 2-8 years Qualification: M. Pharm/ M.Sc. Job Description: HPLC/GC method development for OSD, Topical, Oncology, IH-API. Exposure to regulated, semi-regulated & India markets. Microbiology (Probiotic), STP/Documentation preparation. Position: Executive Experience: 2-8 years Qualification: M. Pharm Job Description: OSD, Topical, Cosmeceutical, and Oncology. Exposure to regulated, semi-regulated & India Markets. Interview Venue Torrent Pharmaceuticals Limited (R&D Centre) Village Bhat, Near Kanoriya Hospital, Gandhinagar (Gujarat) Time: 10:00 AM - 5:00 PM How to Apply Candidates attending interviews are requested to carry the following documents: Latest Resume Passport Size Photo Photocopies of latest salary slips (Last 6 months) Latest CTC breakup Previous experience letters Qualification Certificates and Mark sheets PAN Card/Aadhar Card. Alternatively, you can click here to apply online. For any queries, you may contact: For RA: anupathale@torrentpharma.com For ADL/FND: kedarbhatt@torrentpharma.com Torrent does not engage any third party/agency for recruitment. No amount is charged/accepted, or any security deposit is collected from job seekers during the selection process or afterward for inviting candidates for interviews.

[ddregpharma]

The transition from NeeS to eCTD involves converting non-standardized electronic regulatory document submissions to a globally accepted standard. This requires restructuring and formatting the documents according to eCTD specifications, resulting in improved efficiency, accuracy, and consistency of the submission process.

[freyrsolutions]

Best eCTD Software Tool for global eCTD Submissions

[willingjet]

Life Science Solutions

TRANSLATION OF MEDICAL DOCUMENTS

Life Science Translation

Willingjet provides premium translation services for pharmaceutical, biotech, and medical device companies and CROs with high-quality.  

We have provided language solutions to the life science industry for more than two decades, our professional experts and native-speaking translators have more than ten years of experience, covering more than 100 languages. Willingjet has aquired ISO 17100 , ISO 9001:2015 and ISO 13485:2016 certifications to guarantee our medical translation services complying with the stringent regulatory requirements worldwide.

Medical translation document types

Documents included in drug registration dossier:

M2: Quality summary, non-clinical review and summary, clinical review and summary, etc.;

M3: Manufacturing information, specification, analytical methods and validation, stability study, container closure system for drug substance and drug product;

M4: Pharmacology, pharmocodynamic, pharmacokinetic, toxicology research reports, etc.;

M5: Clinical study protocol, clinical study report, investigator brochure, ccds, package insert, etc.

Documents from the medical device company:

Patient Information

Patient Reported Outcomes (PROs)

Medical device safety and pharmacovigilance document

Clinical trial protocol

Product labeling and packaging

Documents submitted to regulatory agencies

Instructions for use

Technical manual

Medical literature

Medical equipment instructions and installation manuals

Marketing and advertising

Websites, software, mobile apps and IoT

Online learning and training

Legal, financial documents

Documents from the medical device company:

Documents from CROs:

Managing Multi-regional clinical trial in many languages

Clinical trial documents

Patient engagement and recruitment

Contracts and POs

Registration dossier

Contact Us

Professional DTP

We have self-developed DTP software and are good at using industry-standard desktop typesetting and editing tools, including the eCTD format of drug/medical device registration dossier, user manuals, technical documents, and software GUI layout. Our DTP experts have professional knowledge of specific language environments and can produce high-standard dtp design service for any language product.

[aquilasolutions]

Best Practices for Implementing eCTD Submission Software in Your Organization

In the speedy world of drugs and biotechnology, the adoption of Electronic Common Technical Document (eCTD) submission software has become fundamental for smoothing out regulatory cycles. Proficient execution and combination of eCTD submission software can essentially improve efficiency and compliance.

In this blog entry, we will explore the accepted procedures for effectively carrying out eCTD Software inside your organization.

Grasp Administrative Prerequisites:

Before choosing and carrying out eCTD submission software, it's urgent to have an unmistakable comprehension of the administrative necessities well-defined for your district or target markets. Various nations might have special guidelines and assumptions, and your product ought to line up with these to guarantee fruitful entries.

Cross-Useful Cooperation:

Include all significant partners in the execution cycle, including administrative undertakings, IT, quality affirmation, and report supervisory crews. Cross-utilitarian cooperation guarantees that the product addresses the issues and assumptions of all divisions, prompting a smoother combination process.

Select a Complete Arrangement:

Pick eCTD submission software that offers an extensive set-up of highlights. The product ought to help report the executives, form control, electronic mark abilities, and incorporation with other existing frameworks. A comprehensive arrangement limits the requirement for different devices and advances a consistent work process.

Give Sufficient Preparation:

Put resources into thorough preparation for all clients engaged with the submission cycle. This incorporates administrative experts, record creators, and IT faculty. Appropriate preparation guarantees that clients can augment the capacities of the eCTD submission software and decreases the gamble of mistakes during entries.

Information Relocation Arranging:

If progressing from manual or heritage frameworks, plan for information movement cautiously. Guarantee that information from existing reports is precisely moved to the new framework. This incorporates metadata, rendition history, and some other important data. Exhaustive information relocation forestalls information irregularities and mistakes in entries.

Customization for Productivity:

Select eCTD submission software that takes into consideration customization to meet the particular necessities of your association. Customization choices ought to incorporate archive formats, submission layouts, and work process setups. Fitting the product to your association's work process upgrades effectiveness and client fulfillment.

The Bottom Line!!

All in all, effective execution of eCTD Submission Software requires cautious preparation, cooperation, and progressing obligation to progress.

By following these prescribed procedures, your drug or biotech association can improve its administrative cycles, upgrade compliance, and add to the effective conveyance of new medicines to showcase.

[ddiclinical]

Makrocare  Regulatory Publishing & eCTD Submission Services help you to reduce the cost and effort involved in converting paper-based documentation into eCTD.Our Submission Services are designed to facilitate advanced publishing activities and to extend the capabilities of organizations while utilizing the eCTD format.

[talentgrowth]

Asst. Manager - Regulatory

Asst. Manager – Regulatory

Asst. Manager – RegulatoryExperience: min 12 yearsProfile:  a. Must have sound knowledge of regulatory requirements for EU/SA/chile ,  b. Must have submitted documents in CTD / ECTD format to Regulatory market customers such as EU/SA/chilec. c.Must have worked in pharmaceutical manufacturing  OSD formulation companyd. Must have knowledge of CTD / ECTD modulese. d. Should be willing to work…

[meeraoperon]

Drug Master File Submission Guideline

The Drug Master File is a document that is prepared by the medical device maker/manufacturer, in which he/she provides confidential information about the product to USFDA. This document is a submission to the Food and Drug Administration (FDA) that provides the regulatory authority with confidential, detailed information about facilities, processes or articles used in the manufacturing, packaging, processing, and storing of one or more human drugs.

A Drug Master File (DMF) is neither approved nor rejected; it is reviewed by FDA when referenced by an applicant in a regulatory submission.

DMF Preparation and DMF Submission

The Main Objective of the Drug Master File (DMF) is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal products. Beginning on May 5, 2018, new Drug Master Files, as well as all documents submitted to existing Drug Master Files, must be submitted using the Electronic Common Technical Document (eCTD). The Drug Master File (DMF) submissions that are not submitted in eCTD format after this date will be rejected. In the United States, there are 5 types of Drug Master File.

Drug Master Files classified are as follows:

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)

Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III Packaging Material (Note: There appears to be some confusion regarding when a Type III Drug Master File (packaging material) should be submitted. It is not required that packaging information is submitted to the FDA in a Drug Master File.

Read More -  Drug Master File Visit Us - Operon Strategist Contact details –Phone  no -  93702 83428Mail id – enquiry@operonstrategist.com If  You Want Medical Devices Services Consultation For Following. 1. Medical Device Manufacturing 2. CDSCO Registration 3. FDA 510 k clearance 4. Continuous Improvement Program 5. Design Control Requirements 6. QMS Certification Services 7. Manufacturing Plant Layout Design 8. Primary Packaging Consultant 9. CE Marking Consultant 10. Combination Product 11. Medical Device Design And Development 12. Clean Room Design Consultant 13. ISO 13485 Certification 14. ISO 15378 certification 15. Medical Device Process Validation 16. 21 cfr part 820 17. 21 cfr part 210 and 211 18. DMF submission 19. CAPA Management 20. TURNKEY PROJECT CONSULTANT 21. Manufacturing Site Conceptualization

[ddregpharma]

DDReg provides services in eCTD (electronic Common Technical Document) applications, with advantage of not requiring accompanying paper copies. We offer services in eCTD format for submitting applications, amendments, reports, supplements to FDA’s for CDER and CBER. If you have any query please call +1 (302) 391-6010 & click here https://bit.ly/39v80qa

[stevenbennett]

Masters Classes on US Pharmaceutical Regulatory Affairs Professional Certification Program

Live  Webinar: Masters Classes on US Pharmaceutical Regulatory Affairs Professional Certification Program When: Tuesday Jun 15, 2021 - 11:00 AM Duration: 8 Hours.

Click here to Register Webinar

Program describes the essential requirements for obtaining approval of a new drug in the USA, the 'NDA Process'. The program describes preparing submissions using the Common Technical Document (CTD) Form and requirements for obtaining approval of human medicinal products in the US. Courses that are included in this program are: Essentials for Human Medicinal Products; Orphan Drug Application; How to Gain Approval to Market Generic Drugs in the US; Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US; Preparing Submissions in the Common Technical Document (CTD) Format; Electronic Common Technical Document (eCTD); The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA; and Registration of Drugs Based on Monoclonal Antibodies.

Areas will be covered during the Session:

This course  gives a definition of regulatory affairs and outlines the function and evolution of regulation in the pharmaceutical industry as well as providing a source of key legislation and guidelines. National and international regulatory authorities are introduced including the legal frameworks in the USA and EU. It  describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area. The procedures for making an application are detailed, that includes the acquisition of protocol assistance and collection of supporting data. In Europe, the Centralized Procedure is now the mandatory method to gain authorization for marketing of orphan products. Learn what is needed for  the regulatory approval of the Common Technical Document, the use of the Common Technical Document and its structure, and the conversion of other formats to Common Technical Document. And Many more to be covered in the session.

Contact Person:  SAM

+1 3156320735

email@compliance.world

[freyrsolutions]

[aquilasolutions]

Streamline Your Regulatory Submissions with eCTD Templates, Publishing Services, and Software

In the constantly evolving environment of submissions to regulatory agencies speed, accuracy, as well as the compliance of submissions are essential. Electronic Common Technical Document (eCTD) is now the most common format used to submit documents for regulatory purposes, and has changed the way that submissions are submitted. To successfully navigate through this maze pharmaceutical and biotech firms are able to benefit from templates for eCTD, eCTD publishing services as well as software for eCTD.

This blog will look at the ways these tools are changing the process of submitting regulatory documents.

eCTD Templates: The Foundation of Regulatory Documentation

eCTD Templates are designed and developed to provide structured in a standard way that are used for documents that regulate.These templates are valuable due to the following reasons

• Congruity: eCTD template templates are designed to standardize the format of submissions, providing consistency across applications and documents.

• The Compliance: Templates have been designed compliance with regulations to help companies remain in compliance with both global and regional standards.

• Efficiency: Utilizing templates can cut down the time and effort to create submissions, allowing professionals working in regulatory affairs to focus on the content, not the formatting.

eCTD Publishing Services: Expertise in Submission Compilation

eCTD Publishing Service are delivered by experts who are knowledgeable about the intricate details involved in eCTD submissions.The main benefits that come with eCTD publishing services are:

• Technical Expertise: Proficient professionals deal with the complexities involved in eCTD publishing, making sure submissions comply with the requirements of regulatory agencies.

• Efficiency: The outsourcing of eCTD publishing allows teams in-house to concentrate on the most important tasks which saves time and resources.

• International Reach: eCTD publication services usually capable of handling submissions from different regions, which facilitates worldwide market accessibility.

Electronic Content Technology Software (eCTD): Heart of Submission Management

eCTD Software acts as the infrastructure that speeds up the process of submitting. It includes a variety of tools and features that facilitate eCTD creation as well as compilation, submission along with lifecycle administration. The advantages from eCTD applications include:

• Document Management: Storage and retrieval centralized of documents for regulatory purposes.

• Version Control: Ensuring that submissions remain organised and in line with the latest guidelines.

• Collaboration: Facilitating cross-functional teamwork and streamlining the review process.

• Change Management: Effectively monitoring and managing post-approval changes or updates.

• Data Security: Ensure the security of sensitive data.

[regulatoryinstitute]

Online Pharmacovigilance Certification Course - How to Register and Enroll

An online pharmacovigilance certification course is the first step to becoming an established professional in the pharma industry. It is a 12-week training course that gives you the foundation for your career. With the overflowing competitions, it is essential to make sure of your edge over others on the same professional route. 

Register to Pharmacovigilance Certification Online Course

You can search for more information about pharmacovigilance course training before you register or enroll in a program. This way you are 100% sure that your decision is a wise one. Lucrative investments to your career such as enrolling in a 3-month training course. All graduates in any course or degree are qualified to apply for this program. 

Download the admission form online and print the PDF format, which you need to fill out. Mention the mobile number and course that you are interested to enroll in. Choose a courier to send the filled form along with the DD to complete the registration process.

Details and Information Needed

All applicants of the pharmacovigilance certificate course online should fill the PDF form and supply the essential data for their registration. However, there is also an online registration form, which you can initially fill out before printing. First, you need to provide your full name, date of birth, and address. Applicants must also give their mobile number, email, alternate number, ID proof, and upload their photo. 

Signing up for an online pharmacovigilance certification course requires you to select the kind of course that you want to take. There are 5 choices including Post Graduate Diploma in Drug Regulatory Affairs. Others include Advanced Post Graduate Diploma, Post Graduate Diploma, and Certificate Course in Quality Assurance and Control. An eCTD Certification Program for distance learning is likewise available for 4 months of training.

Your eligibility is vital thus, you must also provide your education including your last degree or the last exam is taken. Some working professionals who wanted to enroll in the course training should also indicate their work experience. The preferred payment method should be filled out to complete the registration. 

There are supporting documents that the program requires, which you must comply with. Enrolling in the online pharmacovigilance certification course is the standard step for pharma professional candidates today. This is a program that makes you a more competent and competitive professional in the field of pharmacovigilance.

Pharmacovigilance refers to the activities and science that relates to detecting, assessing, understanding, and preventing drug-related problems. This is a promising and lucrative niche that requires more and more professionals now and in the future. Thus, it will be on demand for years to come, attracting more competition in the process as well. Establish an edge and enroll in an online pharmacovigilance certification course. Get in touch with the Global Institute of Regulatory Affairs now!