Drug- For Manufacturer
Drug- For Manufacturer
We assist the manufacturers in India in preparing the necessary documents and obtaining the respective licenses and approvals for their different drug products and API’s.
Investigational New Drug (IND)
Investigational New Drug is regulated by office of the DCG(I), which also grants approval of manufacture/import of new drugs for marketing in India. Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in India. There are many regulatory aspects associated to it and hence it is better to consultant an expert in this field for smooth approval process.
CliniExperts is your right partner for all your IND needs. For more information contact.
New Drug Approval (NDA)
The process for new drug approval is regulated and may vary depending upon various factors like the country of discovery of new drug, the nature of drug, etc. It is advisable to consult an expert for a smooth, hassle free process.
CliniExperts Regulatory Affairs team offers a one-stop solution to clients to support regulatory needs throughout the entire product lifecycle from the Pre-Investigational New Drug Application meetings through marketing application approval to post-approval lifecycle management. For more information contact us.
Subsequent New Drug (SND)
Subsequent new drug is not defined in any act by the Indian Regulatory Authority, the CDSCO. However it is a term widely used by the CDSCO in their work practice. The process of getting a subsequent new drug approved can be smoothened by consulting the right regulatory partner.
CliniExperts has the best team of regulatory experts which will guide you throughout the process of getting the Subsequent new drug approved. For more information on our services contact.
BE NOC for Export
The requirements for BE NOC are general in nature, however depending on the nature of the drug, disease and studies further specific information may also be required to be furnished by the firm. It is recommended that an expert be consulted for smooth process.
At CliniExperts, the team of experts provides the clients with end-to-end consultation on BE NOC requirements. For more information on our services contact.
Export NOC and Special Code/Neutral Code for NOC
Export NOC and Special Code/Neutral Code for NOC are important documents required by the manufacturer. The process of obtaining these NOCs requires filling of proper documentation. The process of obtaining the required NOCs can be eased by consulting a team of expert from CliniExperts. For more information on our services contact.
Subject Expert Committee (SEC) Meetings
The Ministry of Health & Family Welfare had constituted a Subject Expert Committee, previously known as the New Drug Advisory Committee. The SEC is regulated by the DCG(I). The SEC formulates policy and guidelines for approval of new drugs, clinical trials and banning of drugs from time to time.
At CliniExperts a team of experts will guide you through any of your queries on the SEC. For more information contact.
Toxicity Studies
There are various types of toxicology studies, which need to be performed as per the GLP and the guidelines laid down by the regulatory body. CliniExperts is your right partner for all your toxicological study needs. For more information contact.
Bioequivalence (BE) Studies
Bioequivalence studies are most widely used methods to demonstrate therapeutic equivalence between two drug products. The studies provide an objective mean to assess the possibility of alternate use of two similar generic products. The office of Drugs Controller General (India) at CDSCO (HQ), FDA Bhavan, New Delhi, is the regulatory authority in India for BE studies. The approval and documentation for BE studies is regulated, expert guidance can help smoothen the process to get the necessary approval.
At CliniExperts a team of experts will guide you through any of your queries on the Bioequivalence Studies. For more information contact.
Clinical Trials
The process of obtaining approval to conduct a clinical trial in India requires lot of documentation. At CliniExperts a team of experts will guide you throughout the process and get the necessary approval. For more information on our services contact.
Medical Writing
Medical writing is an integral part at every stage of developing a therapeutic product. CliniExperts is a one stop solution for all your medical writing needs. For more information on our medical writing services contact.
Test Licence
A Test Licence is given for the Small quantities of drugs, the import of which is otherwise prohibited under section 10 of the Drugs and Cosmetics Act and Rules, 1945, may be imported for the purpose of examination, test or analysis subject certain conditions. Obtaining a Test Licence can be a cumbersome process, requiring filing of proper documents. CliniExperts team provides end-to-end consultation service to obtain Test Licence. For more information on our services contact.
Dual NOC
No-Objection certificate (NOC) is required for the import of drugs, items capable of dual use. The permission has to be obtained from the Zonal Offices of CDSCO. CliniExperts will guide throughout the process for obtaining the NOC for drugs with dual use. For more information contact.
Manufacturing Licence
The Drugs and Cosmetics Act, 1940 regulates the manufacturing of Ayurvedic, Allopathic and Cosmetics drugs/products. To obtain a manufacturing licence, documentation process as per the State Licensing Authority and/or Central License Approving Authority needs to be done, whichever is applicable. At CliniExperts a team of professionals guide you throughout the process and helps you get the manufacturing licence. For more information on our services contact.
Form 29 for Test Batch
There are various types of licences and licensing requirement vary depending upon various factors. At CliniExperts, we help you by guiding you throughout the licensing process. For more information on our services contact.
Wholesale Licence
A wholesaler seeking to obtain a Wholesale Drug Licence should fill application form along with the prescribed fees as per Drug and Cosmetic act 1940 and rules 1945. Based on under which schedule the drug falls and for which drugs the wholesalers seeks to obtain the licence, the appropriate Form is issued. CliniExperts team will guide your throughout the process to obtain the Wholesale Licence. For all your Wholesale Licence needs, contact.
Free Sale Certificate
The process for obtaining a Free Sale Certificate can be cumbersome. However at CliniExperts, our team of experts guide you throughout the process. For more information contact.