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  • Contact PDG
  • Home
  • Services
    • Pharmaceutical Consulting Services
    • Strategic Drug Development
      • Strategic Drug Development Services
      • Pharmaceutical Development Programs: Implementation and Oversight
      • Pre-IND Meetings
      • Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)
      • Clinical Trial Design
      • Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2)
      • 505(b)(2) NDAs
      • Generic Drugs: 505(j) ANDAs and Potential Diversification
      • Nonprescription Drugs (OTC)
    • Medical Device Consulting
      • Exempt Devices / 513(g) Submissions
      • Device Pre-submission Meetings and Reviews
      • Facility Inspection Readiness
      • Combination Device and Drug/Biologic Submissions
      • 510(k) Submissions
      • PMA Submissions
    • Post-Launch Activities
      • Drug Post-Launch Activities
      • Post-Marketing Surveillance
      • Drug Labeling
    • Specialty Services
      • Specialty Services
      • Citizen Petitions
      • Legal Support
      • Literature Searches
      • Pharmacokinetic Consulting
      • Quality Assurance & Compliance
      • Scientific and Technical Writing
      • Supplier/Vendor Selection and Qualification
      • Toxicology Consulting
  • Regulatory Updates
  • About PDG
    • About PDG – An FDA Regulatory Consultant
    • Your Pharmaceutical Consultant
    • Careers at PDG
  • Regulatory Resources
    • Regulatory Resources
    • FDA Links
    • International Health Authority’s Websites
  • Contact PDG

Blog

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Post-Marketing Surveillance

The Value of Registries in Post-Market Surveillance

Other BlogBy Third-Party ContributorMay 21, 2021

Post marketing surveillance is the process of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. The drugs and medical devices are generally approved on the basis of clinical trials, which involves relatively a number of…

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Medical device Consultant

Things to Know Before Hiring a Medical device Consultant

Other BlogBy Third-Party ContributorMay 12, 2021

The role of a medical device consultant is to identify the available options, take necessary corrective actions and prepare ways to deal with FDA to help the medical device manufacturers before introducing any device to the market. These consultants should be professionals and highly qualified in the field. But sometimes a few medical device consultants…

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What is the importance of the OTC monograph? What are the risks of taking OTC medicines?

Other BlogBy Third-Party ContributorApril 21, 2021

OTC monograph is widely used as a rule book to detect the level of the OTC in the medicines. Nowadays, it is essential to take help from the monographs, so while having a treatment, it is essential to take help from the monographs that are really very important for you, as OTC drugs contain more…

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Pharmaceutical regulatory consulting

How to choose Pharmaceutical regulatory consulting services?

Other BlogBy Third-Party ContributorApril 12, 2021

When your pharmaceutical company is working on a new project to develop new medicines, in this scenario, all they need is to take help from the pharmaceutical regulatory consulting company so that the project cannot face any burdens at this precious time. So, whenever you are choosing a pharmaceutical regulatory company that will help you…

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Important factors that are needed to be considered for 510(k) submissions

Other Blog, Other BlogBy Third-Party ContributorApril 5, 2021

While working in the fields of medicine, getting certification is the much-needed thing that should be taken care of. In order to obtain certificates from the company, it is needed to have and follow some rules so that you will be able to gain the best results from the end of the service provider. Similarly,…

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Pharmaceutical Industry News

Pharmaceutical Industry News – Keep You update About Pharma Industry

Other BlogBy Third-Party ContributorJanuary 12, 2021

The news regardless of the topic, the day, the place where you live; they have great importance for people’s lives, it is given by the set of communication media that inform us about the most outstanding events. Thanks to the news we can know which route to take towards our work, know when it is…

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505(b)(2) nda

Know about the 505(b) (2) and its benefits

Other BlogBy Third-Party ContributorJanuary 7, 2021

The 505 (b) (2) application is one of three established types of regulatory submissions and may favor pharmaceutical sponsors. The FFDC defines the statutory submission of 505 (b) (2) as an NDA that includes a safety and efficacy investigation, most of which requires applicants to approve such an NDA. An applicant who is an applicant…

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Drug Vendor Selection

Drug Supplier Selection – Choosing a Good Drug Supplier

Other BlogBy Third-Party ContributorJanuary 2, 2021

Not all inputs or raw materials have the same importance, and depending on specific needs, each company may emphasize certain standards and not others. According to your needs it is must to have good Drug supplier selection. But in addition to this, having the right suppliers allows you to have certain control over production costs…

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fda drug labeling guidance

Know About FDA drug labeling requirements

Other BlogBy Third-Party ContributorDecember 5, 2020

The Food and Drug Administration (FDA) has several FDA drug labeling requirements and regulations that various industries must comply with. In June 2006, a new final FDA regulation, “Prescription Drug and Human Biological Product Content and Format Labeling Requirements,” came into effect. This rule is part of the FDA’s initiative to manage the risk of…

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IND consulting

Investigational New Drug Consulting Service – Making Your Drug Development Easy

Other BlogBy Third-Party ContributorDecember 4, 2020

During the development of a new drug, sponsors will show whether the product is safe for early human use and the pharmacologically and clinically relevant activity of the compound that requires further investigation for future commercial growth. If you need any help, the IND consultant will work with or play a role in the Chief Regulatory…

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