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FDApals

Name: FDApals
Address: Pune, 411019, IN
Telephone: +919890512558

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FDApals

FDApals is a division of Perfect Pharmaceutical Consultants pvt Ltd (PPC).

PPC is one of the well-respected and prominent Regulatory Consulting Organization for the life sciences industry.

30/11/2022

FDA OTC Drug Establishment Registration and OTC Drug Listing:
Both U.S.-based and non-US drug establishments that are involved in manufacturing, relabeling, repacking, distributing, or importing OTC drugs for commercial use in the U.S. are required to register and list their products.

FDA drug establishment registration involves submitting the drug establishment information in a Structured Product Labeling (SPL) format. SPL is a coded data format that is adopted by FDA for FDA drug establishment registration and drug listing. OTC drug listing also involves submitting the drug product label as well as drug information in SPL format.

If you are an OTC drug manufacturer and need assistance or OTC drug establishment registration and listing of OTC drug products, FDApals can assist you. FDApals also review your OTC drug label to ensure FDA compliance. Feel free to contact us with any OTC drug-related questions.
Contact No:+91-9890512558
For more info visit:https://bit.ly/3dIPyN5

26/11/2022

Turnkey Solutions for Medical Device Industry: We work on complex technical problems and guide in the layout of the medical device manufacturing plant facility in order to reduce the client's costs and effort for observing individual coordination, and planning.

Turnkey projects assist our customers in lowering total costs and downtime. We also offer our clients operational assistance as well as excellent after-sales support for the installed machinery.

Turnkey Project Consulting Services:
-Plant Layout Design
-Clean Room Design
-Regulatory Compliance
-QMS Certification
-Post Marketing Support

Get in touch to obtain a quote for Turnkey Solutions,
Email-Id:[email protected]
Visit us:https://bit.ly/3O2kX9X
Contact No:+91-9890512558

25/11/2022

The CE Marking Process: The CE Marking Process has six simple, but necessary steps to complete to enable you to CE Mark your product.

Step 1: Identify the Applicable Directive(S)
The first step is to identify whether your product can be CE marked or not. Not all products are required to be CE Marked, only the products that fall within the scope of at least one of the CE Marking Directives.

Step 2: Identify the Applicable Requirements of the Directive(S)
Each Directive has slightly different methods of demonstrating conformity. This usually depends on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements that the product has to meet.

Step 3: Identify an Appropriate Route to Conformity
The CE Marking process is always a self-declaration process however you may need to involve a third party. This is set out in the ‘system of attestation’ and will vary between Directive.

Step 4: Assessment of The Product’s Conformity
When all of the requirements have been established, you need evidence that the product meets the essential requirements of the Directive(s).

Step 5: Compile the Technical Documentation
Technical documentation relating to the product or range of products needs to be compiled.

Step 6: Make a Declaration and Affix the CE Mark
When the manufacturer, importer, or authorized representative is satisfied that their product conforms to the applicable CE Marking Directives, they must complete a Declaration.

If you need help with any part of the CE marking process or any aspect of product compliance, then please contact us...
Email-id:[email protected]
Contact No:+91-9890512558.
More info visit:https://bit.ly/3NvdcsV

23/11/2022

US FDA Agent For Food, Drugs ,Medical Device and IVD Companies:The FDA is responsible for protecting and promoting public health through the regulation of food safety, to***co products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines and biopharmaceuticals, blood transfusions, medical devices and radiation emitting products.FDApals offers a reliable and cost-effective solution for U.S. Agent services for small companies.

Why Choose Our US FDA Agent Services?
1.Established experienced
2.Lowest fees
3.No hidden charges
4.All services under one roof
5.Food facility registration and Medical Device registration and listing are
both free with our U.S. Agent services
6.Strict client confidentiality
Do you have questions about USFDA?
Contact us today, we’re here to help.
Request for a quote:[email protected]
Contact No:+91-9890512558
For more info visit:bit.ly/3GFyfbT

19/11/2022

ISO 15378 Consultant for Medical Packaging Material Manufacturers:
ISO 15378 is a quality assurance standard for Packaging Material used in Pharmaceutical and Medical Packaging. It is developed with reference to Good Manufacturing Practices (GMP).

What are the benefits of ISO 15378 Benefits?
-The manufacturer can improve their proficiency in production processes by following GMP standards
according to ISO 15378 standard.
-Assurance of quality products to your clients. Upgrade customer satisfaction.
-Competitive Advantage over other non-confirmed providers.
-Application of risk management helps to reduce errors associated with the product.
Do you have questions about ISO 15378?
Contact us today, we’re here to help.
Request for a quote:[email protected]
Contact No:+91-9890512558
For more info visit:www.fdapals.com

18/11/2022

FDA Medical Device Registration: If you are a manufacturer of medical devices, you must register with the Food and Drug Administration (FDA). The purpose of registration is to ensure that FDA receives accurate information about your company so that it can keep track of what is being manufactured and sold in the marketplace.
For more info visit:https://bit.ly/3dqCzj4

15/11/2022

China DMF filing for API, Pharmaceutical Excipients and Drug Packaging Materials:An overseas manufacturer of an Active Pharmaceutical Ingredient (API), a pharmaceutical excipient or packaging material must apply for marketing authorization for the product in China through DMF Filling.FDApals provides a variety of regulatory consulting for DMF filing in China.

DMF Filing Services:
FDApals provides a variety of regulatory consulting for DMF filing in China.
-Authorized local agent for product filing.
-Provide application material checklist and date gap analysis, document translation and guidance on dossier preparation.
-Local experts consulting for technology transfer.
Request for a quote:[email protected]
Contact No:+91-9890512558
More info visit:https://bit.ly/3v8oKeW

12/11/2022

Food Safety Certification(FSMA) Services: The goal of this act is to prevent food safety issues in the food supply chain in the United States. The Food Safety Modernization Act (FSMA) is a comprehensive network of the United States' food safety regulatory framework. It affects every stage of the produce industry's supply chain, from farm to fork.

For the first time, FSMA gives the FDA authority to ensure that imported products meet US standards and are safe for US consumers, and particular guidelines for Foreign Supplier Verification are in place.

We can help you with everything from pre-market applications to post-market surveillance and compliance.
Request for a quote:[email protected]
Contact No:+91-9890512558
More info visit:https://bit.ly/3IcXfGk

04/11/2022

Medical device companies must hire experienced ISO 13485 consultants or a consulting firm that is knowledgeable about all risk-class devices. With an increasing emphasis on patient safety, regulatory requirements in the medical device industry are constantly reviewed and amended.

The most recent ISO 13485 2016 specification specifies requirements for a quality management system in situations where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Get in touch to obtain a quote for ISO 13485 Certification,
email-id:[email protected]
Contact No:+91-9890512558
More Info Visit Us: https://bit.ly/3FP8Aew

02/11/2022

eCTD Publishing & Submission: The electronic common technical document (eCTD) format is the industry standard for submitting
applications, amendments, supplements, and reports to the FDA's Center for Drug Evaluation and Research (CDER) or
Center for Biologics Evaluation and Research (CBER) (CBER).
Understanding and successfully applying eCTD requirements to your submissions is critical. These requirements, however, are not always intuitive, and mistakes (both large and small) can occur when documents do not fit seamlessly into the permitted eCTD structure. When this occurs, Sponsors may be forced to make last-minute changes, which may jeopardize their submission timelines. Worse, the FDA may reject the entire submission, which is known as a technical rejection.
Contact us today to find out how we can help you with your next submission.
Contact No:+91-9890512558.
More info visit:https://bit.ly/3M34Zex

28/10/2022

UDI Submission - As a medical device manufacturer, you are required to create and maintain a Unique Device Identification (UDI) system for each medical device in each market that requires it.

A unique device identification system necessitates the label of devices to bear a series of characters that consists of a unique identifier (DI) and production information (PI), created through internationally accepted device identification and coding standards, allowing explicit identification and transparency of specific devices on the market.

As UDI systems expand into more global markets, each with slight variations in requirements, keeping track of what’s required by which agency and how to provide it can be extremely overwhelming. We’ll help you navigate the complicated process to ensure you comply with each.

With intelligence on the most up-to-date requirements, our global regulatory consultants will help you:
-Understand what needs to be done and when
-Identify UDI traceability requirements for each regulatory body
-Gather and organize the required data
-Prepare your submissions
More info visit:
https://bit.ly/3FlWc7C

24/10/2022

May the celebrations of Diwali be the brightest and blessings be the sweetest this year.
Happy Diwali from The FDApals Family!

Address

Pune
411019

Opening Hours

Monday	10am - 6:30pm
Tuesday	10am - 6:30pm
Wednesday	10am - 6:30pm
Thursday	10am - 6:30pm
Friday	10am - 6:30pm

Telephone

+919890512558

Website

https://fdapals.com/contact/

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