Pharma Regulatory Consulting Solution

API First is a one-stop destination for all pharma regulatory services. In a short span of time, we have created a niche for ourselves as regulatory consultants having expertise in a wide array of regulatory activities. Our services include but are not limited to new drug approval, medical device registration, and licensure, FDC approval, Cosmetics Licensure, GMP Layouts preparation, Auditing, Training, etc. We help our clients with various insights, help them to strategize, and support them with various technical know-how so that the documentation is adequate and complies with regulatory requirements. The right strategy not only helps in product selection but also helps in getting expedited approvals.

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Pharma Regulatory Services

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New Drugs Approval

We provide a clear pathway for our Indian manufacturers, Overseas manufacturers as well as importers so that the complete drug approval becomes hassle free and expedited. 

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Regulatory Retainership

We serve as regulatory retainers for a number of pharmaceutical, cosmetics, medical device and nutraceutical companies. 

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Labelling Support

We support our client to design suitable labels of their product and make it sure that they comply with all the applicable regulations.

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Cosmetics

Cosmetic licensure and registration process in India and we provide the best guide to overseas manufacturers importers to make their entry into the market smooth and hassle free.  

Portal Registration

Portal Registration

We help our clients for carrying out the registration activities on these portals. Cdscoonline.gov.in, cdscomdonline.gov.in, statedrugs.gov.in.

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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.

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Medical Devices

We provide medical device regulatory services to manufacturers in India, overseas manufacturers and importers. Our Services: registration, Application filing, document preparation, etc.

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Ethics Committee Registration

We help ethics committees in preparation of the documents and subsequent filing of their applications. We follow-up the case till the registration is granted. 

Pharma GMP Services

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Project Management

We have a team of experts manages both green field and brown field projects. We prepare plant layouts related to OSD formulations, bulk drugs, parenteral etc.

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Guidance for WHO/GMP Audits

We help pharmaceutical manufacturers of MSME category to upgrade their facilities, prepare necessary documentation,etc. And also achieve the alluring WHO GMP and/ or EU GMP certification for their manufacturing plants.

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QMS Implementation

We train and support the staff of our clients in implementation of the QMS at their respective sites. We help the firms while facing the audits.

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Audits

We conduct various types of audits: GMP audits, GLP audits, Facility Feasibility Audits, GAP assessment audits at client’s and/ or their vendors to ensure that they are in a state of compliance with all the international requirements.

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Training

We conduct a variety of training on site, off site and online: GMP, GLP, Good Documentation Practices, Good Distribution Practices, Good Warehousing Practices, facing Audits, etc.

Pharma Licensing Services

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Drug Manufacturing License

A drug license is required for manufacturing and sales as per the Government laws. We are well versed with the application process and will help in portal registration, preparation and filing of the applications till the grant of license..

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Retail & Wholesale License

We help the firms to get the retail and wholesale drug license throughout the country. We support firms in this whole process of filing the applications till the grant of license…

Pharma Distribution Services

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Authorised Agent

According to Government laws: Foreign Drug manufacturers who are trying to launch their products in India can make an application only through an Indian Authorized agent. APIFirst, can act as an authorized agent/ registration holder...

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Distribution

We provide our international clients with import and warehousing facilities, distribution channelization, invoicing and record maintenance service. With vast knowledge of the market will help in choosing the right distrubutor.

Why Us?

“We guide our customers through the complete regulatory process, right from dossier preparation to filing to final approval.” At API First we try to provide solution to all your concerns viz. strategizing, product selection, product development, dossier preparation, filing, liasoning, query responses, customer identification, registration holder and what not. We do not rely on publicity to gain access to clients, rather our work speaks for itself. We rely on customer satisfaction, our success rates, ethics, transparency, client’s feedback.

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What Our Clients Says

theon

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
adley group

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

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

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

Our Clients

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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.