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Consulting, Submission And Inspecting Services Of FDA Consultants

Wednesday, September 7, 2016

FDA Consultants consist of experts who understand what FDA and several other regulatory bodies’ need of medical devices, pharmaceuticals, foods, cosmetics, dietary supplements and certain other regulated products available for sale in US or other countries all through the world. Regardless of your business level of size, they have the proficiency to address your regulatory desires. Most of the consultants are ex-FDA compliance officials who play a vital role in describing the regulations for US foods.


Their first-hand knowledge on regulatory practices as well as procedures will give you an added guarantee that you get quality advice at a very reasonable cost.

They could help you in carrying out new food or dietary products/ingredients to market and to ensure that they are developed, manufactured/processed, labeled, keep distributed or available for transaction in compliance with the customary regulations.

They can also ensure that cosmetic, pharmaceutical and medical devices comply with appropriate regulations.

Cosmetics:

FDA Consultants provide a comprehensive range of cosmetic consultations, submission and also auditing services including
  • Assessing the safety of your cosmetic ingredients
  • Reviewing cosmetic labeling to assure that it meets the FDA requirements
  • Making color additive petitions for getting FDA approval
  • Attending and arranging meetings with official agencies on behalf of you
  • Providing advice and updates on current policy developments and regulatory at FDA
Food:
  • Reviewing advertising and labels for conformity with regulations
  • Designing clinical studies with the intention to substantiate label claims
  • Providing technical support to low acid and acidified canned food developers and helping in registering their processes and facilities with FDA
  • Finding out the safety of food ingredients and preparing petitions for food additives, GRAS notifications and reviews, food contact substance announcements and risk assessments
  • Serving as professional witness and offering testimony on litigation engaging disputes on regulatory food matters
Dietary supplements:
  • Conducting GMP audits and offering consulting assistance over GMP compliance
  • Reviewing labels and advertisements of dietary supplements
  • Evaluate the safety of the ingredients included in the dietary supplement and in turn, prepare a NDI notification to be reviewed by FDA
  • Reviewing laboratories to make sure that they are in compliance with the GMP requirements
  • Interpretation of rules and regulations of FDA and other regulatory agencies as they are related to products and practices.
  • Providing recall advisory and assistance when needed
Pharmaceuticals:
  • Accomplishing due diligence audits
  • Conducting quality system, GMP and pre-approval audits for manufacturers and vendors
  • Interpreting FDA policies and guidance documents in relation with  GMP
  • Offering guidance on importing procedures and helping in getting clearance of products by means of FDA and US customs during the time of entry
  • Preparing SOPs for recalls, compliant handling, employee practices, change control, failure investigation and so on.
Medical devices:
  • Carrying out quality system audits for the manufacturers of medical devices
  • Helping medical device manufacturers to implement quality control and assurance, document control, regulatory affairs and complaint handling procedures as well
Tobacco:
  • Implementing quality systems recognized FDA
  • Monitoring of tobacco activities, dockets along with regulation development
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