About Us:

API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India. With a 100% success record, API First boasts of a team, who not only help you with the filing process but performs the complete technical and administrative review of the data submitted to us. This helps to reduce the concerns raised by the regulators and helps to expedite the approval process. The transparent and supportive approach have helped us won accolades among our clients.
Drug Regulatory Approvals is a combination of hard work and smart work. When to apply, what to apply, how to apply, where to apply, whom to apply etc. are the questions that comes to mind when we are entering to any market or introducing a new drug product in the market. It is a well-known fact that “Time Lost is the Opportunity Lost”. It holds true for the introduction of newer drugs also. Later you enter the market, lower will be your market share. Loosing time in the regulatory approvals normally hurt much more.
In addition to the new drug approvals, we have separate and dedicated teams handling the layout designing of drugs and nutraceuticals manufacturing plants as per GMP requirements of USFDA, MHRA, EU, TGA, PIC/S, WHO, Schedule M etc.
Apart from the regulatory services as such, team API First leaves no stone unturned to be a part of the process and makes the experience a hassle free one.
Our blog services provide you a dose of knowledge on various aspects of GMP, regulatory pathways, new drug discoveries, new drug approvals, pharma events etc.

Quality Policy

API First is committed to provide the transparent, systematic, error free guidance to our clients for smooth sailing through various regulatory processes, a fundamental element of our Company’s Mission and Vision.

As a long term ethically binding policy, we target, and commit ourselves to provide guidance for drug approvals in India and other regulatory countries. We continuously strive to achieve customer satisfaction by ensuring that the services offered meets various quality parameters and within stipulated timelines. We anticipate customer’s perspective and support them adequately with all required technical data and information in a time bound manner.

We continually improve and review our various procedures to make them more efficient, relevant with changing national and international regulations and to improve consumer satisfaction with the quality of services. We comply with all relevant statutory and regulatory requirements.

Providing training to our employees is a regular feature in our calendar that fosters team spirit in addition to inculcate them with recent guidelines, notifications and advancements in the regulatory requirements around the world.

We stringently adhere to implementing Quality Management Systems and are committed towards making continual improvements to the same.