New Drugs Approval Services | Vaayath Consulting Services

New Drugs Approval Services – Vaayath is one of the leading pharmaceutical consultants which is offering New Drug Services in India. We have a committed, well-experienced team that has remarkably deep understanding of the Indian Drug Regulations. Vaayath has a proven track record of getting new drug approval in India which includes products launched first in India. Subsequent drug approvals and fixed dose combinations. Apart from new drug approval Vaayath is offering a comprehensive set of various allied services such as test license applications, import of reference samples, clinical services such as Bioequivalence studies and Clinical trials, registration of drugs and import licenses etc.

India is a vital market that many pharmaceutical companies wishes to enter as a part of their strategy to increase their area of operation and promote their new products. However, they often found themselves entrapped due to misunderstanding of existing and ever changing drug regulations. This not only leads to delay in product launch but also waste their very important resources i.e. time and money. Vaayath makes this process easier for clients by providing right support from the start to the end i.e. from initial consultation to final approval. We help to formulate strategies right from product development to product launch.

Vaayath is a trusted New Drug Consultant India who provides a range of services for pharma companies to bring their new drugs to market. This comprises the development of regulatory strategy, dossier compilation, submission of data to the Drug Controller General of India (DCGI), responding to the queries raised, support in conducting clinical studies such as BE and Phase III and post-approval/ post marketing compliances.

Vaayath has a strong understanding of the regulatory framework in the Indian market as their strength. We stay abreast of any new regulations or guidelines, and hence, keep our clients in a state of compliance with the latest rules. Further, we ensure receipt of correct, timely and transparent advice till the project completion. 

We have a team of experienced professionals who understand the significance of fast and early access to the market especially for the pharmaceutical industry. We efficiently navigate through the approval process, assisting our client in getting their new drugs approved in India at the fastest possible pace. So, call us now and get the best new drug approval services for your pharma business. 

 

How New Drugs Approval Services helps in bringing drugs into the Pharmaceutical Market?

New Drugs Approval Service provided by Vaayath plays a crucial role in helping Pharmaceutical companies go through the algorithm of an intricate regulatory system. We resolve the puzzle of complex regulatory guidelines and help our clients in bringing innovative medicines to the Indian market.

The services in question thus offer highly qualified and experienced expertise in New Drug Approval Process in India so that companies fully adhere to all the requirements as laid down under New Drugs and Clinical Trial Rules, 2019.

Vaayath as a New Drug Consultant in India provides a priceless and incomparable guidance to pharmaceutical companies by helping them understand the regulatory approval process. Our team of experts helps the technical team to frame product specifications during product development, help in preparation of various regulatory documents, provide guidance in understanding and responding to the queries raised by the regulatory agency and hence expediting the complete approval process. This strategy not only accelerates the approval process but also assures that the company has met the all the regulations laid under the law for ensuring the quality, safety and efficacy of the drug under approval.

The utilization of the knowledge and resources provided under New Drugs Approval Services assists pharmaceutical companies in shortening and smoothening the drug approval process by avoiding regulatory delays. This helps to accelerate the launch of drug into the market and have an early access which aids in becoming brand leader. Further, it is beneficial to the end consumers i.e. patients as they have an early access for the innovative quality medicines which are vital for their medical treatment.

 

What are the essential conditions to obtain the New Drug Approval in India?

To Achieve New Drug Approval in India, pharmaceutical companies have to follow various regulations laid down in Drugs and Cosmetics Act, 1940 and various Rules such a Drug Rules, 1945, New Drugs and Clinical Trial Rules, 2019 etc. which are enforced by the Office of Drug Controller General of India (DCGI). We as a New Drug Consultant India and your partner in your success takes the onus onto ourselves to help you navigate and sail through all the complex regulations.

The document requirements are more or less similar to any CTD format wherein all the requirements pertaining to Administrative Information, CMC data, Non Clinical and Clinical data is desired. Upon review of the submitted documents, the O/o DCG (I) may grant approval or may seek further clarifications.

Majority of the clarifications sought pertains to CMC, Non Clinical and Clinical Data. Phase III clinical trial and Bioequivalence study is often desired but their applicability depends on case to case basis.  

Once the specified conditions for marketing of a new drug in India are fulfilled, the DCGI reviews the final report and the decision to approve the marketing of the new drug is taken. The new drug is then entitled to be added to the List of Approved Drugs in India, which is being administered and updated by the O/o Drugs Control General of India (DCGI). This list serves as  a reference for every healthcare professional or pharma company.

 

What opportunities do Pharmaceutical Companies have with New Drugs Approval Services outsourcing?

Outsourcing New Drug Approval Services has its advantages to the pharma business owners, pharma manufacturers and importers in India. Through the appointment of a New Drug Consultant in India, companies gain immediate access to various experts having hands on experience with the understanding and handling of local drug regulations. A well read and experienced consultant can make the New Drug Approval Process in India – a cakewalk. 

Having an experienced New Drug Consultant India not only guides through the approval process but he can review the documentation before submission to the Authorities. This helps to weed out potential queries which may later become a hurdle in the approval process. Lesser the queries, Faster will be the approval process. This will save time and money for the pharma companies. Highly experienced New Drug Consultant India can help out in expedited dossier preparation, submission, and approval of the drug product.

Furthermore, outsourcing can essentially enhance competitiveness. Experienced Consultants know exactly the standards that are required by the Authorities and they include the same in their dossiers. Hence, they help to design an application that conforms to all the requirements.

Also Read: Top List of Banned Drugs in India

Experienced and qualified Pharma Consultants possess up-to-date knowledge of the newest regulations and codes of practice. This consequently reduces the probability of errors or omissions that could later cause delays in approval.

Lastly, producing your product abroad can be cost-effective. Rather than operating a regulatory affairs unit on a full-time basis. And the companies can rent those services on an as-needed basis, which can dramatically reduce overhead expenses.

This means the outsourcing of New Drugs Approval Services enables pharmaceutical companies to meet the approval process efficiently, effectively and minimize the queries and regulatory concerns etc. This facilitate the release of innovative drugs in the shortest time possible.

 

Why choose Vaayath as the Best New Drug Consultant in India?

Vaayath, qualifies or possess all the credentials that any firm will be looking for in their regulatory partner. Some of them are highlighted below:

  • Expertise: A team of experts who have the necessary experience on the regulatory requirements for New Drug Approval in India.
  • Guidance: We are a team of experts having experience in the New Drug Approval Process in India and hence, providing comprehensive guidance and directions throughout the regulatory process to ensure all the required regulations and regulatory guidelines are met.
  • Efficiency: Team Vaayath offers an efficient pathway for new drug approval processin India. This ultimately saves cost and resources for pharmaceutical companies.
  • Comprehensive Services: Vaayath provide all-time assistance where they guide their customers from the initial consultation to ultimate approval. And thus enabling the clients to focus on other important things. Our services are expanded to all the areas related to drug approval process. Some of the services such as clinical trials, BE studies etc. are channeled through various channel partners. 
  • Regulatory Knowledge: Vaayath doesn’t make the mistake of falling behind with the current laws and regulations as the company makes sure that the provided consultations are timely and accurate in line with the latest regulatory guidelines.
  • Track Record: We have a proven track record of New Drug Approval in India. Our valuable clients speak for our performance.
  • Cost-Effectiveness: It seems cost-attractive to subcontract the drugs new approval service to Vaayath Consulting Service rather than owning a regulatory affairs team on your own.
  • Access to List of Approved Drugs: Through Vaayath, gain access to the comprehensive List of Approved Drugs which acts as a powerful means of staying abreast on drug industry updates.
  • Post-Approval Support: We render this post-market surveillance to ensure continuous compliance with regulatory requirements.

 

FAQs

Q1. What is New Drugs Approval Services?

Ans- Vaayath offers a comprehensive New Drug Approval Services that work along with our client and their cross functional team in getting DCGI approval for the sale and marketing of new drugs in India.

Q2. What is the New Drug Approval process in India?

Ans- New Drug Approval process follows various regulations laid down in Drugs and Cosmetics Act, 1940 and various Rules such a Drug Rules, 1945, New Drugs and Clinical Trial Rules, 2019 etc. which are enforced by the Office of Drug Controller General of India (DCGI).The document requirements are more or less similar to any CTD format wherein all the requirements pertaining to Administrative Information, CMC data, Non Clinical and Clinical data is desired. Upon review of the submitted documents, the O/o DCG (I) may grant approval or may seek further clarifications.

Q3. What exactly does the New Medicines Consultant do during that approval process in India?

Ans- A New drug Consultant in India is a knowledge partner of pharmaceutical companies at a time when they need expert guidance and support.

Q4. What is the method of accessing the List of Approved Drugs in India?

Ans- The Approved Drug List in India is put up on the Central Drugs Standard Control Organization (CDSCO) website. And which has the regulatory agency charged with periodically updating the list. However, you can visit our website for the comprehensive list of approved drugs in India.

Q5. What is the Procedure of the Drug Registration Process India?

Ans- To register a new drug in India, one needs to submit an application to the DCGI along with related information about the drug’s safety, efficacy, and quality. The DCGI examines the application and approves the drug product if the application is found satisfactory.

Q6. How long is the process of New Drug Approval in India?

Ans- The pace for Drug approval in India can significantly vary and mainly depends on how extensive the application is and the response from the regulatory authorities. Normally it takes between 6 months to a year.

Conclusion 

Vaayath is a dependable industry associate for pharmaceutical companies. Join us and get the best Pharma Regulatory Consultant Services in India. 

 

Related Blogs