Pharma Regulatory Consulting Services India

Pharma regulations are considered as a cipher difficult to crack by most of the pharmaceutical companies. API first with a team of experts and a huge network of allied services has set up a benchmark in providing consulting services related to pharma regulations. Our team has expertise in handling new drug approval, registration and license of medical devices, registration and license of cosmetics, registration of ethics committee and registration of the firm on various government online portals. Our team of legal and GMP experts are on board of many reputed firms as regulatory retainers. We also provide support in framing replies to show cause notices and help our clients in handling legal issues. Our regulatory team also provides services w.r.t. review of labels and ensure that they are in a state of compliance with all the regulations.

New Drugs Approval

We help our clients in strategizing, formulation development, dossier preparation, filing and resolving queries. We help our clients understand the requirements of the drug approval process, so that there is no ambiguity or confusion in the process to follow. This makes their new drug approval experience stress free. Transparency and accountability are basic principles imbibed in the team handling new drugs approval.

Cosmetics

Recently India has come up with a new set of Rules namely Cosmetics Rules, 2020. These rules define the process to be followed for manufacturing and importing Cosmetics in India. We help our clients to file the applications related to registration and licensure of cosmetics as per new requirements and regulations. This helps our clients to receive expedited approvals.

Medical Devices

India in 2017, framed new set of rules namely Medical Device Rules, 2017. We help our clients in categorizing their Medical Devices into the four classes as defined in the rules. The classification helps to understand the documentation requirements and help to frame the timelines for approval.

Regulatory Retainership

As regulatory retainers, associated with pharmaceutical firms, we support our clients in their day-to-day regulatory issues. We help our clients in handling regulatory concerns raised by regulatory bodies and help them to frame replies to show cause notices issued to them. We also provide up-to-date information regarding new notifications so the same can be implemented at the earliest.

Portal Registration

India has moved from manual application system to e-filing of applications. Most of the government regulatory agencies are currently accepting applications through online mode only. We help our clients in registering on the relevant portals. This helps to reduce duplication of registration and target only the relevant portals.

Ethics Committee Registration

We help our clients in registration of both Independent and Institutional ethics committees. We help our clients in preparation of the documents and subsequent filing of their applications. We also provide support in renewal of ethics committee registrations.

Labelling Support

We help our clients to prepare product labels in compliance with all the applicable laws. Various laws related to labelling includes Drugs Rules, Cosmetics Rules, Medical Device Rules, Legal metrology etc. Any deviation to the applicable guidelines may invite legal and penal action.

Legal Services

Our legal experts help the client in framing replies to the show cause notices, Not of Standard Quality (NSQ) letters or any other legal notices issued by the Drug Authorities or any other Government departments.

Leeford Healthcare Limited

API First has become our single point contact for resolving all our regulatory issues. The camaraderie they enjoy with our staff has made the job easy for us. The team at API First knows their job well and are extremely professional in approach. Team API First really functions as an extension of our in-house team rather than an external support. It’s this type of collaboration and pharmaceutical expertise that’s make them stand apart from other consulting firms. The team at API First is highly knowledgeable and responsive. They provide a very quick turnaround time between discussion and results. API First has time and again proved to a useful resource for us and supports well in handling regulatory issues of our vast portfolio. Keep up the good work Team API First!

Amit Gupta

Managing Director / Leeford Healthcare Limited

Logos Pharma

We had been interacting with the team API First for quiet sometime. They have encouraged us to venture into new drug approvals. New drug had been an unknown territory for us. Team API First has a passion for, and comprehensive understanding of, every single aspect of New Drug approval in India. Their approach, right from strategizing to filing of application till the final approval is remarkable and contagious. Their suggestions and contributions are extremely helpful; but, most significantly, they train, motivate and instil a confidence among us to achieve something which was considered difficult if not impossible. We wish success for API First in their future endeavours.

Ankur Gupta

Director / Logos Pharma

Adley Group

Team API First has been an invaluable resource, providing support and directions for getting approval of new drugs and other regulatory permissions. They build strategies backed by data which is an important aspect while planning for new drug launches. The commitment level is exemplary. The entire team is transparent and provides guidance from the product selection to the final approval. Team API First is resourceful, knowledgeable and is expert at regulatory laws and approval processes applicable in the country.

Rahul Batra

Director / Adley Group

Theon Pharma

API First has been instrumental in rekindling our interest in New Drug approval in India. The clarity of pathway and transparency in approach for regulatory filings has made API First our formidable partner. Team API First has always been responsive and they never shy away from replying to any sort of information sought from them. They regularly update about the new developments and regulations in the field of drug manufacturing. The team API First is experienced, knowledgeable, result-oriented, committed and professional in their approach about execution of the project. Their expertise & regulatory knowledge puts them on par with other globally recognized regulatory consultants. Highly recommended! I wish API First best wishes in their future endeavors!

Amit Bansal

Director / Theon Pharma

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.