DS & DP
DS/DP Registration​​​​​​​
At Unibest Industrial, we understand the critical importance of securing regulatory approval for both drug substances (DS) and drug products (DP). Our DS/DP Registration services are designed to help pharmaceutical and biotech companies navigate the complex regulatory landscape, ensuring that your active pharmaceutical ingredients (APIs) and finished dosage forms meet the highest standards of quality, safety, and efficacy.​​​​​​​
Regulatory Strategy and Compliance

Tailored Regulatory Plans

Our experienced team develops customized strategies for DS/DP registration, tailored to meet the specific requirements of global regulatory authorities such as NMPA, FDA, EMA, and others.

Regulatory Compliance

We ensure that your DS/DP registration complies with all relevant guidelines, including ICH (International Council for Harmonisation) standards, GMP (Good Manufacturing Practice), and other regulatory requirements.

Documentation Support

We assist in preparing comprehensive regulatory dossiers, including CTD (Common Technical Document) modules, covering quality, safety, and efficacy data.
Regulatory Strategy and Compliance

Tailored Regulatory Plans

Our experienced team develops customized strategies for DS/DP registration, tailored to meet the specific requirements of global regulatory authorities such as NMPA, FDA, EMA, and others.

Regulatory Compliance

We ensure that your DS/DP registration complies with all relevant guidelines, including ICH (International Council for Harmonisation) standards, GMP (Good Manufacturing Practice), and other regulatory requirements.

Documentation Support

We assist in preparing comprehensive regulatory dossiers, including CTD (Common Technical Document) modules, covering quality, safety, and efficacy data.

GMP Compliance

Our QA team ensures that your manufacturing processes and facilities are fully compliant with GMP standards, both domestically and internationally.

Facility Audits

We conduct thorough audits of your manufacturing sites to identify and address any potential issues before submission.

Process Validation

We support the validation of your manufacturing processes to ensure consistency, reproducibility, and regulatory compliance.
Quality and Manufacturing Support
Quality and Manufacturing Support

GMP Compliance

Our QA team ensures that your manufacturing processes and facilities are fully compliant with GMP standards, both domestically and internationally.

Facility Audits

We conduct thorough audits of your manufacturing sites to identify and address any potential issues before submission.

Process Validation

We support the validation of your manufacturing processes to ensure consistency, reproducibility, and regulatory compliance.
Data Compilation and Analysis

Quality Data Compilation

We compile and analyze data from raw material testing, in-process controls, and final product testing to demonstrate the quality of your DS/DP.

Stability Studies

We support the design and execution of stability studies to establish shelf-life and storage conditions for your products.

Analytical Method Validation:

We ensure that your analytical methods are validated and meet regulatory expectations for accuracy, precision, and reliability.
Data Compilation and Analysis

Quality Data Compilation

We compile and analyze data from raw material testing, in-process controls, and final product testing to demonstrate the quality of your DS/DP.

Stability Studies

We support the design and execution of stability studies to establish shelf-life and storage conditions for your products.

Analytical Method Validation:

We ensure that your analytical methods are validated and meet regulatory expectations for accuracy, precision, and reliability.

Submission Management

We manage the entire submission process, ensuring timely and accurate filing of your DS/DP registration application.

Regulatory Correspondence:

We assist in addressing any questions or requests from regulatory authorities, ensuring timely and comprehensive responses.

Post-Approval Support

We provide ongoing support for post-approval activities, including annual reporting, change control, and regulatory updates.
Submission and Post-Submission Support
Submission and Post-Submission Support

Submission Management

We manage the entire submission process, ensuring timely and accurate filing of your DS/DP registration application.

Regulatory Correspondence:

We assist in addressing any questions or requests from regulatory authorities, ensuring timely and comprehensive responses.

Post-Approval Support

We provide ongoing support for post-approval activities, including annual reporting, change control, and regulatory updates.

General Inquiry

info@unibestcn.com

CDMO Services

cdmo@unibestcn.com

Business Development

bd@unibestcn.com

CALL US

+86-574-27855666

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Products are for R&D use only and are not intended for human use. We do not sell to patients.

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