U.S. FDA Registration Assistance

Tobias-Hricrin is one of the most experienced regulatory consulting firms to obtain the FDA clearance, FDA registration and to meet the FDA’s general requirements for drugs, food (including dietary supplements and sea food), medical devices and cosmetics. Supported by our many years of experience, we understand the problems that you can encounter in the path of achieving compliance and can assist you in finding solutions easily. We have strong technical expertise in each area to understand your product requirements and to provide you with cost and time-efficient regulatory advice.

 

The appointment of  an FDA US agent for foreign companies is a mandatory requirement and also it is required for FDA registration purposes. We understand the importance of the role of a US agent and will assist you with all FDA related communications efficiently and with a quick transfer of information through the FDA.

 

Ask us about all of your questions about FDA compliance, regulatory requirements for products and  also any questions on marketing your products in USA. There are no fees to answer these questions, it is one of our  free services. We offer the highest quality services with guaranteed low fees.

Services

Area of Expertise

  • Drugs
  • Establishment registration and renewal

  • Labelar code, NDC number and drug listing

  • ANDA submission in eCTD format

  • DMF submission in eCTD format

  • Gap Analysis of Regulatory Submissions

  • ESG setup assistance and training

  • Medical Device
  • Establishment Registration and Device listing

  • Premarket Notification 510(k)

  • Premarket Approval (PMA)

  • Investigational Device Exemptionon

  • Quality System (QS) regulation

  • Labeling requirements

  • Medical Device Reporting (MDR)

  • Food
  • Food facility registration and renewal

  • Prior notice filing

  • Process Filing for Acidified and Low-Acid Canned Foods (LACF)

  • Labeling review

  • Other
  • Regualtory advise

  • Regulatory training

  • Patent search and advise

  • Sourcing and Contract manufacturer identification

  • Regulatory updates

Not interested in reading? Just watch our videos to understand regulatory requirements and about our services.

Why We

No advance payments, pay after verification of our services.
Integrated regulatory solution with core technical assistance.
Consulting in right direction considering your future business and compliance requirements.
Realize what is required, don’t just spend. We offer cost saving regulatory advice.
We have regulatory expertise to help you.
Free guidance on basic regulatory compliance requirements.
We assure best pricing with high quality services.
Your business is safe, we highly believe in customer confidentiality.
Fast and reliable service.

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