Dear All,
We are reaching out to introduce our company as a Regulatory affairs consultant:-
Brief Introduction:
Planwey Global Services Pvt. Ltd is a turnkey solution provider with in-house regulatory team for registration of medical devices, In Vitro Diagnostics, cosmetics & drugs our teams work in sync with our clients to commercialize healthcare products in the Indian medical industry. We assist and draft the required documents to the our clients in obtaining the other relevant licenses such as Manufacturing License, WholeSale License, import license, Post Approval Change application & Test License form MD 17, PE evaluation for RTPCR kits for Class C&D products, Registration Certificate to successfully import the products into India. As an Indian Authorized Agent, Planwey Global Services Pvt. Ltd provides high quality and professional services and develops long term relationships for the Indian market & Neighboring Market.
We also providing Manpower placement and recruiting, Selecting, Interviewing, Training and Employing all types of executives, Middle Management Staff, Junior Level Staff, Workers, Labourers Skilled/Unskilled/High-Skilled required by various Industries and organizations including providing security services, Labour contractors, Industrial, Commercial, Housing and other security services and workers for office management and to conduct employment bureau and to provide consultancy and other services in connection with requirements of persons and manpower supply in India and abroad.
Our Services:
Medical Devices & IVDs: We provide documentation guidance to our clients and drafts as per their request.
Follow-ups with CDSCO for faster approval.
Cosmetics: We provide documentation guidance to our clients & follow ups with CDSCO for faster approval.
Food Licensing: We provide documentation guidance to our clients.
Drug Regulatory Licensing: We provide documentation guidance to our clients.
Regulatory Compliance Services: We are most compliant HR Services providers Refinement Global Services Pvt. Ltd is uniquely positioned to address your requirements in the domain of regulatory and labour law compliances.
Manpower Services: We provide human resources services to various industries and diverse functional roles, offering staffing, payroll processing, recruitment, compliance and training services.
Temporary Staffing: We assist corporate clients in their Regular or Seasonal staffing requirements by providing contractual or temporary staffing services. We work with our clients for hiring or identification of temp resources and take the selected resources on our payroll for providing the payroll support services to the client. Alternatively we also take on our payroll, resources pre-identified by clients or existing ones from any other sources.
WHY TO CHOOSE Planwey Global Services Pvt. Ltd.
When time and performance are critical to your project... We do the job right the first time without any needless delays and added project costs."
We provide cost-effective quality assurance support that can save your company time and money by identifying potential problems.
Consultancy FEE STRUCTURE
S.No | Description | Price (in INR) |
Cosmetics Product Registration |
1 | Consultancy charges for drafting required documents and declarations and applying online. | INR 7000 per products for all classes (GST Extra as applicable) Product Fees Additional will be charged if we will pay. Approval timeline 60 days from the date of submission |
Medical Device & IVD |
1. | Consultancy charges for drafting DMF, POA and declarations and applying online. | INR 10,000.00 per product for all classes (GST Extra as applicable) |
2 | Product fees | As per applicable |
3 | Drafting Test License | INR: 1000 per product. (GST Extra as applicable) |
4 | TL Product fees | As per applicable |
WORKING PROTOCOL
¨ Assisting in following up with CDSCO ¨ Compilation and creation of Import License and Review of Dossier | ¨ Compilation and creation of Import License and Test License |
Timeline of the approval
Type of Application | Timeline of approvals |
Form MD 15 (Import License) | Approval Timeline (30 to 90 days) |
Form MD 17 (Test License) | Approval timeline (10 to 30 days) |
Terms & Conditions of Payment:-
1. 25% before starting work for applications
2. 50% after submission of Applications
3. 25% after getting approval
4. Good Services Taxes & Levies: Extra as applicable
5. Product Fees Extra as applicable
Thanks & Regards,
B K Gupta
Planwey Global Services Pvt. Ltd.
Mobile: +91-9899343232
Email ID: bkgupta@planweyglobal.com
Website: http://www.planweyglobal.com
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