PIMS Registration

PIMS Registration Services | SSA Tax

PIMS Registration (Product Information Management System) is an essential step for businesses in the pharmaceutical, healthcare, and FMCG sectors to ensure compliance with regulatory standards for product data. The PIMS system allows companies to maintain accurate, up-to-date, and comprehensive product information in one centralized database, facilitating smoother operations, regulatory compliance, and transparency.

At SSA Tax, we provide comprehensive PIMS Registration services, ensuring that your business meets all legal requirements and your product data is correctly maintained and accessible. Our team will guide you through the entire registration process, helping you achieve compliance with ease.

What is PIMS Registration?

PIMS Registration refers to the process of registering products under the Product Information Management System, an online system introduced by the Central Drugs Standard Control Organization (CDSCO) for the pharmaceutical, medical devices, and healthcare industries. This system ensures that manufacturers and importers provide detailed, standardized information about their products to regulatory authorities.

The PIMS system is designed to streamline the approval process for new products, making it easier for businesses to submit data and comply with industry regulations. It helps the Central Drugs Standard Control Organization (CDSCO) and other authorities track, verify, and maintain up-to-date information about pharmaceutical and medical products in the market.

Why Do You Need PIMS Registration?

• Regulatory Compliance: PIMS registration ensures that your products comply with the CDSCO and other relevant regulatory authorities' requirements for safety, quality, and effectiveness.
• Streamlined Product Approval: By registering your products in the PIMS system, you can expedite the process of product approval, saving valuable time and resources.
• Accurate Product Information: The PIMS system allows manufacturers, importers, and distributors to provide detailed and accurate product information, reducing errors and inconsistencies.
• Improved Transparency: PIMS registration increases transparency and accountability in the pharmaceutical and healthcare industries, ensuring that regulatory authorities can track and verify the information on all products in the market.
• Facilitates Market Entry: For businesses looking to introduce new products or expand their portfolio, PIMS registration is essential for ensuring smooth market entry and compliance.
• Better Product Data Management: By centralizing product information in a single, organized system, businesses can better manage their data, ensuring consistency across all channels, including marketing, sales, and distribution.

Who Needs PIMS Registration?

PIMS Registration is mandatory for businesses involved in manufacturing, importing, and distributing pharmaceutical products, medical devices, and related healthcare items. This includes:

• Pharmaceutical Manufacturers: Companies that manufacture drugs, tablets, capsules, syrups, and other medicinal products.
• Medical Device Manufacturers: Manufacturers of medical devices, diagnostic tools, and equipment.
• Importers: Businesses importing pharmaceutical products and medical devices from other countries.
• Distributors and Wholesalers: Companies involved in the distribution of pharmaceutical products and medical devices.
• Healthcare Product Providers: Companies selling healthcare-related products, including dietary supplements, cosmetics, and hygiene products.

Documents Required for PIMS Registration

To successfully complete the PIMS Registration process, businesses need to submit various documents that provide detailed information about their products. These may include:

1. Product Information: Detailed product description, including the brand name, active ingredients, dosage form, strength, and packaging details.
2. Business Registration: Proof of business registration, such as GST Registration, Certificate of Incorporation, or Partnership Deed.
3. Manufacturing License: A copy of the Manufacturing License or Import License issued by the relevant authorities.
4. Product Lab Reports: Laboratory test reports confirming the safety and quality of the product.
5. Certificate of Analysis: A certificate from an accredited lab proving the products compliance with regulatory standards.
6. Power of Attorney: A signed power of attorney authorizing a representative to submit the application on behalf of the company (if applicable).
7. Labeling Details: Product labeling information, including packaging, barcodes, and ingredient details.
8. List of Product Variants: Information about various product variants, including dosage strengths, packaging sizes, and other details.
9. Marketing Authorization: Any approvals or authorizations received from regulatory bodies for marketing the product in India or abroad.

PIMS Registration Process

The PIMS Registration process generally follows these steps:

• Step 1: Create a PIMS Account
  Register on the PIMS portal by creating a user account for your company. Youll need to provide basic company information during registration.
• Step 2: Submit Product Details
  Upload the required documents and detailed product information, including product composition, manufacturing process, and testing reports.
• Step 3: Verification by CDSCO
  The CDSCO will review your application, validate the product information, and assess the submitted documents.
• Step 4: Issuance of Registration Number
  Once your product data is verified and approved, you will receive a PIMS Registration Number, confirming your products compliance with regulatory standards.
• Step 5: Compliance and Updates
  After receiving PIMS registration, you must ensure ongoing compliance with the system, including updating product details and submitting annual reports.
• Step 6: Renewal (If Applicable)
  PIMS registration is valid for a specified period. If required, you will need to submit an application for renewal before the expiry date.

Why Choose SSA Tax for PIMS Registration?

Expert Guidance: Our experienced team understands the complexities of PIMS registration and will guide you step by step through the process.

• Comprehensive Services: We provide end-to-end support, from document preparation and application submission to post-registration compliance.
• Timely Processing: We ensure that your PIMS registration application is processed quickly and efficiently, minimizing any delays in your business operations.
• Affordable Solutions: At SSA Tax, we offer PIMS registration services at competitive rates, ensuring that your business remains compliant without overspending.
• Ongoing Support: Beyond the registration process, we offer ongoing compliance services, helping you stay up-to-date with regulatory changes and renewals.
• Trusted Advisors: With years of experience in regulatory services, SSA Tax is a trusted partner for businesses in the pharmaceutical, healthcare, and FMCG sectors.

Get Started with PIMS Registration Today

Ensure your products are fully compliant with industry regulations and streamline your approval process with PIMS registration. At SSA Tax, we offer efficient, reliable, and affordable services to help your business get registered under the Product Information Management System.

Contact us today at 9773346539 or fill out our online form to get started with PIMS Registration and ensure your products meet regulatory standards with ease.