Pharmaceutical Regulatory Retainership Service India

Pharma regulations are a tricky area. With ever changing regulations around the world and lack of harmonization among various regulators, it becomes difficult for a pharmaceutical manufacturer to keep a track of newer guidelines and regulations. In India, there are many notifications, guidelines, rules etc. which are introduced or amended in a year. Additionally, many court directions, general notices are published which leads to confusion regarding implementation of the same.

It has also been experienced that different state regulators normally implement the same rules, in a different way which also leads to chaos.

Sensing this, many pharmaceutical industries are engaging the services of Subject Matter Experts (SMEs) to understand these changes so that they can maintain their state of compliance.

We at API First, have a team of experts who constantly keep pace with these changing regulations. Our network helps to understand the regulations better and resolve the ambiguities if any.

Accordingly, many industries across India and Abroad have hired our firm as regulatory retainers. We serve as regulatory retainers for a number of pharmaceutical, cosmetics, medical device and nutraceutical companies. Various services provided by API First to our clients as regulatory retainers are as follows:

Our experts train the staff of our clients for better implementation of the regulations.
We support our clients in their day-to-day regulatory issues.
We help them prepare replies to various government letters, show cause notices etc.
We guide our clients regarding new notifications and provide them the information at the earliest so that they can implement the newer regulations well within the time frame.
Help in addressing the compliance concerns raised by regulatory authorities.
Preparation of standard procedures inline with the changed or newly introduced regulations.
Support in harmonization of procedures.
Support in preparation of audits.
Any type of regulatory support that may arise from time to time.

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.