Pharmaceutical Development Grouphttps://pharmdevgroup.com/
Joined: August 17th, 2020
Articles Posted: 6
- 513(g) - Section 513(g) of the Federal Food, Drug, and Cosmetic Act is providing a means for device manufacturers to obtain information about the Food and Drug Administration’s views regarding the classification of a device
- Medical device consulting - PDG offers one-stop-shopping to include 513(g) requests for information, pre-submission meetings (formerly pre-IDE meetings), IDE filing and Institutional Review Board (IRB) approvals, 510(k) and PMA submissions.
- Pharmaceutical consultant - Pharmaceutical Development Group (PDG) assists FDA regulated firms in the navigation of the U.S. submission, approval and post-marketing procedures across a variety of dosage forms and therapeutic areas.
- Pharmacovigilance consultants - Pharmacovigilance consultants are often interdisciplinary trained experts with extensive experience in the pharmaceutical industry.
- Regulatory affairs services - PDG Consultants is providing Regulatory Affairs Services to help ease company management of their regulatory documentation.
- Regulatory consulting - FDA Regulatory consulting
Know about the 505(b) (2) and its benefits
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 and has not obtained a r...
FDA Drug Labeling Guidance
Chemist and druggist- we all are very familiar with these two names, and they are both related to each other as well. In the medicine zone, a chemical compound made pills and tablets or other medicines are generally known to us as drugs.
What is Drug Labeling?
Like the other things related to our daily life, medicines are very much essential and essential ...
What does a pharmaceutical consultant do?
The role of the consultant/the consultancy helps defining the mission and vision of a company. It objectively provides the tools that management needs to achieve the objectives set out in its strategic plan. And if we export this model to the pharmacy, we will see that we are not talking about anything different. Well, the work carried out by a Pharmaceutica...
What is to know about adaptive randomized clinical trial design?
Adaptive design clinical trials are a controlled experiment in human volunteers that is used to evaluate the safety and efficacy of treatments or interventions against diseases and health problems of any kind. Adaptive design clinical trials also determine pharmacological, pharmacokinetic effects of new therapeutic products, including the study of ...
AN OVERVIEW OF GMP AND CGMP GUIDELINES
Because of the thalidomide tragedy in the U.S., the FDA (FOOD AND DRUG ADMINISTRATION introduced in 1940, GMP (GOOD MANUFACTURING PRACTICES). In 1963, the World Health Assembly supported CGM and stated that all companies, factories should follow GMP.
In 1978, GMP was modified to CGMP and regulated by the FDA. CGMP works to ensure a quality standard of drugs...
FDA ESTABLISHMENT REGISTRATION GUIDANCE IN 2020
In the U.S., every drug producer and manufacturer have to register in the FDA (FOOD AND DRUG ADMINISTRATION) before selling it to the market; we term this as Establishment Registration in FDA. Registration in the FDA means the FDA is aware of the medicines, medical devices, drugs, and other related product consumption by its people in the U.S.
The products ...
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