#eCTD

[newsjet]

AfriSummit 2024: Uniting for a Healthier Africa

Uniting Masterminds and Industry leaders to Shape the future of Regulatory Landscape in Pharmaceutical sector of the African continent. CAIRO, EGYPT – (AfricaNewswire.Net) — AfriSummit 2024, an initiative by PRA Consultancy, organized by Hubplus Events in collaboration with Pioneers, will take place from November 3-6, 2024, at the Grand Nile Tower in Cairo, Egypt. This significant event brings…

[ddregpharma]

The Benefits of eCTD- DDreg Pharma

The eCTD offers numerous advantages compared to traditional paper-based submissions. It simplifies the submission process by allowing easy compilation, submission, and tracking of regulatory submissions. Electronic submissions reduce errors and improve review efficiency, leading to faster approvals and cost savings for pharmaceutical companies. To learn more about eCTD submission, read our blog.

[alphagreenresources]

Reduce your carbon footprint with the help of green energy.

Clean energy is becoming important in the fight against air pollution. Especially in valley cities like Los Angeles, a haze of smog can be seen hovering over the population centers. There is a vast population in the city, and that means a lot of pollution.

At some point, you might decide you want to switch to green energy. Reduce your household's carbon footprint by switching to renewable energy sources like solar panels, wind turbines, and perpetual motion free energy motor generators. Generally speaking, local Ectd Submissions are feeling the financial pinch of the present economic downturn. Nonetheless, incorporating new sustainable energy sources would result in the creation of new employment opportunities. Greater prosperity results from increased tax revenue, which in turn increases the number of available jobs.

Human health is being negatively impacted by air pollution. Studies have shown that those living in smoggy areas have a higher mortality rate than those living in cleaner environments. In terms of protecting the environment, sustainable energy sources are a need. However, a smog-free environment made possible by renewable energy sources is something that everyone should have access to.

Lung cells are damaged by air pollution, leading to inflammation and edema. The immune response of the Supplier Verification Program is compromised by smog, making it easier for infections to take hold. Lung infections can spread to other parts of the body and cause a wide variety of symptoms. Realizing that exposure to air pollution will lower one's standard of living clarifies the necessity for a sustainable, low-cost method of generating electricity. As a result, the strategy will be of greater importance than ever before.

One strategy for ensuring a better quality at www.alphagreenresources.com of life is to pursue alternative energy generation projects, such as those using windmills, solar panels, and magnetic free energy motors. Until a drastic change is made, the population will increase and air quality will worsen everywhere.

[darkmaga-retard]

Cutting corners?

Hedley Rees

Aug 30, 2024

The Pharmaceutical Supply Chain for Safety Testing

In this post below, AlisonW commented on the various supply chain ‘irregularities’ that have now become apparent in the pharmaceutical supply chain, especially in relation to SARS-CoV-2 injections:

J P Morgan Global Alternatives, the Biotechnology Scam, and Tony Blair

Aug 29

This prompted me to say more about the practicalities of safety testing in the pharmaceutical supply chain. Here we go:

Drug Development Regulations and the Supply Chain

The program of development is dictated by regulatory rules and guidance. A prospective Clinical Trial Sponsor (CTS) has total responsibility for every aspect of the supply chain being put in place. One or more companies may be producing at each stage (raw materials, starting materials, drug substance, drug product, finished product), depending on the supply chain strategy envisaged by the prospective CTS.

Sufficient Drug Substance (DS) will be produced to satisfy the needs of in vitro (test tube) and in vivo (animal) testing. The vast majority is used for in vivo testing in animal models. There is no requirement for the compound to be in any dosage form at this stage.

Sufficient safety data that will subsequently be included in Module 3 and Module 4 of the Electronic Common Technical Document (eCTD) must be collected and analyzed by the prospective CTS. Typically, the data are collected from the contract development and manufacturing organizations (CDMO(s)) and contract research organizations (CRO(s)) carrying out production and testing.

If the prospective CTS considers the data can support an application to embark on trials in humans

[sudheervanguri]

Aarti Pharma Labs, a leading name in the sector, is hiring for Regulatory Affairs Executive, Sr. Executive, and Dy Manager positions. This is a chance to advance your career in regulatory affairs Located in Nerul, Navi Mumbai, Aarti Pharma Labs is committed to advancing the field of chemistry and pharmaceuticals. If you hold an MSc/Ph.D. in Chemistry and have between 2-10 years of experience in regulatory affairs, this could be the perfect role for you. Job Details and Requirements Job Title: Regulatory Affairs Executive / Sr. Executive / Dy Manager Location: Nerul, Navi Mumbai, Maharashtra Number of Positions: 05 Qualification: MSc / Ph.D. in Chemistry Experience: 2-10 Years in Regulatory Affairs Eligibility Criteria: Expertise in DMF filing and eCTD publishing is essential. Must have technical knowledge and the ability to offer guidance on regulatory documents. Team management experience is an added advantage. Key Responsibilities In this role, you will take on several crucial tasks to support Aarti Pharma Labs' regulatory submissions and product management: DMF Coordination: Collaborate with multiple departments to facilitate the preparation and submission of DMFs (Drug Master Files). Document Review: Assess various documents, including LOAs (Letters of Authorization) and CEPs (Certificates of Suitability). Change Control Management: Oversee and implement regulatory change controls as necessary to maintain compliance. Annual Reports and Amendments: Handle the submission of annual reports and DMF amendments in eCTD format. Regulatory Queries: Respond to queries from both customers and regulatory authorities effectively and promptly [caption id="attachment_62019" align="aligncenter" width="930"] Aarti Pharma Labs Hiring for Regulatory Affairs Executive/Sr. Executive/Dy Manager[/caption] How to Apply Interested candidates who meet the above criteria are invited to apply. You can submit your resume to the contact details below: Contact Person: Yogendra Budhaji Raut (Corporate HR) Email: yogendra.raut@aartipharmalabs.com

[pleasepublish]

eCTD Publishing Best Practices: Streamlining Regulatory Submissions.

Discover essential eCTD publishing best practices to ensure successful regulatory submissions, from planning and software validation to consistent structuring and thorough reviews. https://www.pleasepublish.com/blog/ectd-publishing-best-practices/

[karajage]

Regulatory Services

The electronic Common Technical Document (eCTD) is a standardized electronic format used for submitting applications, amendments, supplements, and reports to regulatory authorities such as the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and other Health Authorities (HAs) worldwide. eCTD submissions streamline the creation and review of Electronic Regulatory Publishing data, offering the flexibility to incorporate metatags, hyperlinks, and bookmarks. This format enables efficient assessment and lifecycle management of submissions, ultimately expediting market approvals/authorizations.

With extensive expertise in global eCTD publishing trends and submission formats (e.g., eCTD/Non-eCTD Electronic Regulatory submissions [NeeS]), Freyr facilitates multi-country filings, data compilation, publishing, and dossier dispatch.

We have a team of experts proficient in a wide range of technologies including:

Insight Publisher, Validator

Veeva Vault RIM Suite (Submissions, Submissions Archive, Publishing), Veeva Vault Promomats & Veeva Quality Docs

Lorenz Docubridge, eValidator

Extedo EURS Validator

eCTDXpress

ISIS Publisher/Tollbox

Our team is equipped to provide comprehensive support across these technologies to meet your needs effectively.Health Authority by CountryApplication and Submission TypeSubmission Format Food and Drug Administration (FDA) USAInvestigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA), Over-the-Counter (OTC), Drug Master Files (DMF Submissions), Structured Product Labeling (SPL) Submissions, and Supplemental New Drug Application (SNDA Submissions)

Originals, Amendments, Annual Report Submissions, Labeling Supplement Submissions, Periodic Adverse Drug Experience Report (PADERS), Briefing Book, eCTD Baseline Submissions, Ad Promo Submissions, and eCTD Submissions for Lifecycle Management (LCM)eCTD European Medicinal Agency (EMA)Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and National Procedure (NP)

Clinical Trial Application (CTA), Originals, Variations, AtoQs, Renewals, ASMF eCTD Submissions, and Medical Device SubmissionseCTD Health CanadaNew Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), and Supplement to a New Drug Submission – Confirmatory (SNDS-C)

Abbreviated New Drug Submission (ANDS)

Supplement to Abbreviated New Drug Submission (SANDS)eCTD

[seedpharma1]

Special access scheme (SAS) medicines

Unlock your success with Regulatory Affairs Consultants in Australia We specialize in eCTD submissions and Reference Listed Drug RLD approvals, ensuring streamlined regulatory processes.

[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.

[swapnamakro]

Global Regulatory Publishing and eCTD submission Services | MakroCare

MakroCare Regulatory Publishing and eCTD Submission Services help you to reduce the cost and effort involved in converting paper-based documentation into eCTD.

[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 Pharmaceuticals Ltd is holding Walk-in Interviews for multiple roles in ADL (Analytical Development Laboratory), FnD (Formulation Development), and RA (Regulatory Affairs) at their R&D Centre in Gandhinagar, Gujarat. This is an exciting opportunity for experienced professionals in the pharmaceutical industry to join a leading company in the sector. If you have the right qualifications and experience, don't miss this chance to build your career with Torrent Pharmaceuticals. Walk-in Interview Details Date: 15th September 2024 (Sunday) Location: Torrent Pharmaceuticals Ltd, R&D Centre, Gandhinagar, Gujarat Time: 10:00 AM to 4:00 PM Interview Venue: Torrent Pharmaceuticals Limited (R&D Centre), Village Bhat, Near Jear Kanoriya Hospital, Gandhinagar, Gujarat. Candidates are required to carry their latest resume, passport-size photo, salary slips, and relevant qualification certificates for the interview. Open Positions Torrent Pharmaceuticals is hiring for the following departments: 1. Analytical Development Laboratory (ADL) Position: Executive Experience: 3-8 years Education: M.Pharm Key Responsibilities: HPLC/GC method development for OSD (Oral Solid Dosage) and API (Active Pharmaceutical Ingredient). Exposure to regulated, semi-regulated, and India markets. Specialization in complex generics, F2F, topical formulations, oncology, probiotics, and solid-state characterization. 2. Formulation Development (FnD) Position: Executive (FND) Experience: 3-8 years Education: M.Pharm/M.Sc Key Responsibilities: Experience with oncology, peptides, and alternative vendor development. Exposure to the EU/US market with pre-approval experience. [caption id="attachment_58459" align="aligncenter" width="930"] Torrent Pharma Walk-In Interview for Quality Control and Production[/caption] 3. Regulatory Affairs (RA) Position: Executive Experience: 3-8 years Education: M.Pharm/M.Sc Key Responsibilities: Dossier compilation for Module 2 and 3. Regulatory filing for various dosage forms like solid oral, injectables, topicals, and ophthalmics. Experience with DCP/MRP/National filings for EU countries, including the UK. Knowledge of ANDA submissions, eCTD compilation, and query responses. How to Apply To apply for any of the open positions, please attend the Walk-in Interview on 15th September 2024 at Torrent Pharmaceuticals Ltd, R&D Centre. Make sure to bring the following documents: Latest Resume Passport-size Photograph Last Month’s Salary Slip CTC Breakup Details Previous Experience Letters Qualification Certificates and Mark Sheets PAN Card/Aadhar Card For queries, you can contact: ADL/FND Queries: vilshashah@torrentpharma.com Mobile: 6359621127 RA Queries: ra-anopathale@torrentpharma.com Important Notes Candidates who have been interviewed within the last 6 months are not eligible to apply. Torrent Pharmaceuticals does not engage third-party agencies for recruitment. No fees or security deposits are required during the recruitment process.

[pleasepublish]

Automated Regulatory Publishing Software & Free eCTD Tools - Please+Publish

Streamline regulatory publishing with robust automation. Enjoy free eCTD software for quality control, formatting, and manual process elimination. Try it now! https://www.pleasepublish.com/publishing-automation/

[seedpharma1]

Unlock your success with Regulatory Affairs Consultants in Australia We specialize in eCTD submissions and Reference Listed Drug RLD approvals, ensuring streamlined regulatory processes. https://seedpharma.com/services/regulatory-support/