API & Excipient

API & Excipient

Fig.1 API and Excipient

The active pharmaceutical ingredients (APIs) and excipient industry play a crucial role in the pharmaceutical sector by providing essential ingredients for the production of drugs. APIs are the biologically active components responsible for the therapeutic effects of medications, while excipients are substances that support the formulation and stability of pharmaceutical products. Compliance with regulatory requirements and quality standards is of utmost importance to ensure the safety and efficacy of these ingredients.

Protheragen-ING Lab provides one-stop solutions for regulatory support tailored to your needs in the pharmaceutical industry. Our expertise in this field ensures seamless navigation through the complexities of drug master files (DMFs) and import regulations. From registration to listing, we provide end-to-end support to streamline your API and excipient processes.

Main services of Protheragen-ING Lab

Our company focuses on the unique regulatory requirements for API and pharmaceutical excipient registration to accelerate the entry of your drugs into the Chinese market. We can provide comprehensive services to assist manufacturers in registering their products in China.

Our company is qualified to become a qualified and licensed domestic agent and assumes compliance obligations for API and pharmaceutical excipient manufacturers that do not have offices in China.

DMF Registration Consulting Service

Our team of regulatory experts specializes in preparing and submitting DMFs. We understand the intricate details involved in compiling comprehensive and well-structured DMFs that meet the regulatory guidelines set by various health authorities. By leveraging our expertise, we can assist you in preparing DMFs for APIs and excipients, ensuring compliance and facilitating the approval process.

  • Preparation and submission of DMFs to regulatory authorities.
  • Maintenance and updates of existing DMFs to comply with regulatory changes.
  • Expert guidance on DMF requirements and documentation.

Professional services from registration to listing

Regulatory Strategy Development:

We will work closely with you to develop a customized regulatory strategy tailored to your specific needs. We will analyze the regulatory landscape, identify potential challenges, and devise effective solutions to streamline the registration and listing process.

  • Tailored regulatory strategies to navigate the complex landscape of global regulations.
  • Risk assessment and mitigation strategies to anticipate regulatory challenges.
  • Continuous monitoring of regulatory updates and guidance documents to adapt strategies accordingly.

Registration Assistance:

We will assist you in preparing all the necessary documentation for API and excipient registration, including technical dossiers, quality control documents, stability data, analytical methods, and manufacturing process details.

  • Evaluation of API & Excipient registration requirements based on regulatory guidelines.
  • Preparation and submission of registration dossiers to regulatory authorities.
  • Timely follow-up and communication with regulatory agencies to expedite the registration process.

Fig.2 Regulatory Strategy Development

Quality Assurance and Compliance

We provide comprehensive quality assurance support, including gap analysis, risk assessments, auditing services, and implementation of quality management systems. Our aim is to help you maintain the highest standards of quality and meet regulatory expectations.

  • Development of robust quality systems to meet regulatory standards.
  • Conducting audits and assessments to ensure compliance with multiple quality guidelines.
  • Implementation of corrective and preventive actions (CAPA) to address non-compliance issues.

Technical Support:

  • Technical consultancy for API & Excipient selection, characterization, and compatibility studies.
  • Assistance in formulation development and optimization.
  • Troubleshooting and resolution of technical challenges throughout the product lifecycle.

Partner with us for comprehensive API & Excipient solutions that drive regulatory compliance, enhance product quality and accelerate market entry. Contact us today to discuss your requirements and embark on a journey toward regulatory success.