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Regulatory Pharma Consultants of India
Regulatory Pharma Consultants of India
Arham Consultants (India) Pty. is a New Delhi, India based company providing professional regulatory services to the Indian & International manufacturers of Pharmaceuticals, Medical Devices and Cosmetic product.We are very well versed with the process of getting approval of Finished Product formulations by preparation of Rationale & Justifications , Literature Search & collecting Expert Letters from Reputed Institutes like JIPMER, PGI, VELLORE. AIIMS etc.
Delhi,
Delhi,
India
(prbd.net)
25/09/2011
Arham Consultants (India) Pty. is a New Delhi, India based company providing professional regulatory services to the Indian & International manufacturers of Pharmaceuticals, Medical Devices and Cosmetic products and benefitting from its logistical location in the city of the Indian FDA and near the Manufacturing hubs of Himachal Pradesh and Uttaranchal in India.
Being in the profession for more than 5 years now, the company fulfils the Indian FDA service requirements such as Overseas Product Registrations, Import, Export & Manufacturing Permissions and Pharma Price Regulatory Compliance.
When talked on our function of New Drugs Manufacturing Approvals our technical team provides a very specialized service which entails the Manufacturing Approvals of FDCs and Single Molecule New Drugs on Stability Study , Bioequivalence Study, Clinical Trial Study or on Toxicity Study. Additional to the Consultancy & Strategy Development for Approval of Finished Product formulations by preparation of Rationale & Justifications , Literature Search & collecting Expert Letters from Reputed Institutes like JIPMER, PGI, VELLORE. AIIMS etc the company also gets for its clients the Import Permissions / Manufacturing Approval of Bulk Drugs in India.
The Indian FDA Export Services provided by us is by getting Export Permissions for the export of Bulk drugs and Formulations, providing Export Dossiers in country specific CTD and ACTD formats and Legalization & Attestation of Export Documents from the Buyer Country Embassy / Consulate.
On the Imports in India front, we consult and liaison on Registration of foreign Manufacturing Premises , Import Registration of individual Formulations, Bulk Drugs , Medical Devices and Cosmetics and then providing Import Licences. To enable the foreign Manufacturers in filing their Registration applications, our technical team interacts between the FDA and the foreign manufacturers as the Indian Agent for the Pharmaceuticals , Medical Devices or Cosmetics Facilities / Products Registrations.
The Indian Government also demands Price Compliance by the Pharmaceutical manufacturers and the company serves by Appealing against any Overcharging order/penalty imposed by the Government.
The company also advices the Indian Manufacturer Exporters on the local FDA Registrations in various countries of the world, and facilitates the most accurate and cost effective Clinical Trials, NDDS Trials, Bioequivalence / Bioavailability Studies, Animal Toxicological Studies and Stability Studies as per country specific guidelines and ICH / ACTD / EUCTD formats.
The objective of the company is to understand and implement on the importance of bringing the clients product to market as quickly as possible and in the most cost effective FDA regulatory compliance.
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Arham Consultants is a Pharma Regulatory Consultants.
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