Understanding the CEP requirements for API/drug substances
The process of submitting a Certification of Suitability (CEP) to the European Directorate for the Quality of Medicines and HealthCare (EDQM) is initiated. It is important to have a clear understanding of the requirements for API/drug substances. Templarpharma has a team of Regulatory experts with in-depth knowledge of the EDQM guidelines for CEP submissions.
Expertise in filing CEPs for quick approval of MAAs/ANDS
The process of submitting a CEP to the EDQM can be complex, and it requires a high level of expertise to ensure a smooth and quick approval process. Templarpharma’s Regulatory team has extensive experience in filing CEPs with the EDQM and can provide guidance to API manufacturers to help them obtain the necessary approvals for their products.
Comprehensive services for CEP submission
Templarpharma offers comprehensive services for the compilation, review, and submission of Certification of Suitability (CEP) Submissions to the EDQM. From initial consultation to final submission, our team provides support throughout the entire process, ensuring that all requirements are met, and the CEP is submitted in a timely and efficient manner.
CEP submissions for all types of APIs
Extensive experience in managing the submission of Certification of Suitability (CEP) to the European Directorate. The Quality of Medicines and HealthCare (EDQM) for various types of Active Pharmaceutical Ingredients (APIs). These APIs using chemical, fermentation, and sterile processes. Our team of experts has extensive knowledge and experience in handling CEP submissions for a wide range of products.
Preferred Regulatory partner for API manufacturers
With our proven track record of successful CEP submissions to the EDQM. Team of experts provides customized solutions tailored to the needs of each client, ensuring that their products meet all necessary regulatory requirements.
Letter of Access (LoA) for drug product applications
Templarpharma can assist API manufacturers in obtaining a Letter of Access (LoA) of CEP received from the EDQM. Which can be provided to drug product applications like MAA to all the EU countries. Therapeutic Goods Administration (TGA) of Australia. Instead of submitting an Active Substance Master File (ASMF)/Drug Master File (DMF), a pharmaceutical company may choose to submit an Abbreviated New Drug Submission (ANDS) to Health Canada (HC)
Compliance with EDQM guidelines
Working with a Regulatory partner who has an in-depth understanding of the requirements for CEP submissions is crucial to ensure compliance with EDQM guidelines. A team of experts who are constantly update with the latest guidelines and regulations. Guaranteeing that our clients’ products meet all the necessary requirements for approval.
We strive to provide our clients with customized solutions to their specific needs while maintaining compliance with all regulatory requirements. Experts also ensures that all submissions are within the appropriate timelines to prevent any delays in approval. Templarpharma’s commitment to quality and compliance is evident in our track record of successful CEP submissions. We work closely with our clients to ensure their satisfaction and provide continuous support throughout the submission process. Our team also prepares responses to Health Authority queries (RTQs) for quick approval of CEPs.
Templarpharma Expertise in Certification of Suitability (CEP) Submissions
- Identifying the Regulatory starting material and route of synthesis for APIs/drug substances.
- The design of specifications for starting materials, raw materials, excipients, packing materials, in-process materials, intermediates, and drug substances is undertaken.
- Setting the strategy and limits for genotoxic and elemental impurities.
- inalize stability protocol, process validation protocol, hold time study protocol, degradation study protocol, and analytical method validation protocol.
- Provide review support for the respective reports to ensure accuracy and completeness before submission.
- Conduct a gap-analysis of source documents/data generated for CEP submission.
- Ensure the source documents/data align with the current EDQM requirements/guidelines.
- Compile, review, and submit the CEP in line with EDQM requirements for APIs.
- Publish the CEP in eCTD/NeeS/PDF formats in accordance with the EDQM guidelines.
- Evaluate change controls for Post-Approval Changes (PAC) to ensure that they comply with the relevant regulations and guidelines.
- Conduct a regulatory assessment of PAC and develop a variation submission strategy.
- Compile, review, and submit Variations (Type IA/Type IAIN/Type IB/Type II) to CEPs for PAC in accordance with the EDQM variation guidelines.
- Ensure that all submissions are made within the appropriate timelines to avoid any potential delays in the approval process.
- Develop a regulatory strategy and prepare a response to Health Authority queries (RTQs) to facilitate the timely approval of CEPs.