Food Facility Registration at the FDA is a must for all owners, operators, or agents who oversee domestic or foreign food facilities in the US. Let us help you to get your food facility registered quickly with ease and efficiency. Click on the button below to know more.
If you are involved in the process of manufacturing, packaging, re-packaging, or re-labelling of drugs, then get your FDA registration right away. It may be drugs used for humans or animals. It doesn’t matter if you are a domestic or foreign manufacturer. Click below to let Perfect Pharmaceuticals Consultants handle the entire process.
If you are involved in the process of manufacturing, packaging, re-packaging, or re-labelling of Medical Devices, then get your FDA registration right away. It may be software for running the medical device or actual hardware itself. It doesn’t matter if you are a domestic or foreign manufacturer. Click below to let Perfect Pharmaceuticals Consultants handle the entire process.
What would you rather do? Focus on your manufacturing, your establishment, your product? Or spend time and effort in communicating with the US FDA. Compliances are needed, leave the paperwork and interpretation to us. You can increase your profits by focusing on your growth. Get in touch with us to appoint us as your US FDA Agents.
What would you rather do? Focus on your manufacturing, your establishment, your product? Or spend time and effort in communicating with the US FDA. Compliances are needed, leave the paperwork and interpretation to us. You can increase your profits by focusing on your growth. Get in touch with us to appoint us as your US FDA Agents.
Do you feel your product needs a wider audience? Your medical device can reach a better patient demographic outside the U.S.A. If you want to your medical device on the shelves in the European Union and most other countries globally, then get the CE Mark for your Medical Device.
The Unique Device Identification (UDI) System for medical devices is a regulatory process set by the US FDA. It can get tricky and confusing to pave your way through the entire process. Click on the button below to let us help you with your UDI submission for the US FDA.
Food Labelling Review compliance with the rules may take a considerable time along with the understanding and knowledge of the rules. Get your food labels reviewed easily and hassle-free with us. Click on the button below to know more.
Over-the-counter or OTC drug products are available to consumers without the need for a prescription. However, the FDA evaluates the ingredients and labelling of these products before granting permission for their marketing and sale. Let us help you with your OTC Drug Product Registration to ensure your products are marketed well.
It is a daunting task to handle your eCTD submissions. Even a small mistake in your eCTD publishing can cost you a lot and result in refusal by the FDA to receive your application. Click on the button below to let us help you with your eCTD submissions.
The Investigational New Drug (IND) application falls in the first category and the New Drug Application (NDA) falls in the second category of marketing approval requests. You will need to fill out forms and fulfil all requirements to market a new drug in the US. Click this <button> to understand the exact process.
If you are a company that is involved in manufacturing and marketing of generic drugs, you need to fulfil the ANDA Submission. Perfect Pharmaceuticals has your back to help you with the entire process smoothly and efficiently.
The Drug Master File or DMF is submitted to the US FDA to provide confidential information that the manufacturer does not wish to share with anyone else. Click this button below to understand the process and get your DMF submission done smoothly.
Going through the Food Safety Modernization Act (FSMA) Rules can be time consuming and a daunting task. Let us help you get through this process with ease and efficiency. Click on the button below for a smooth transition.
Being a foreign company and trying to sell drugs or pharmaceuticals in the United States can be hectic and time consuming. If you wish to market your medical devices, food, dietary supplements, or drugs, in the United States, click on the button below to connect with us today!