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Regulatory & Medical Services

Working as a flexible partner, our Medical Writing Solutions team thoughtfully develops accurate messaging for a range of audiences. Whether it’s developing protocols and informed consent forms or a new drug application, Evolve Life dive into the details to deliver it all with full regulatory compliance.
- Prepare & Submit Regulatory dossiers as per regulatory guidelines. - Liaising & Following up with Regulatory authorities. - Consultation of Drug & Device Regulations - Global Clinical Trials - Regulatory Submissions  - Comprehensive gap analysis of regulatory data - Electronic Common Technical Document (eCTD) services , publishing  and                       regulatory authority submission management - NCEs, NMEs, devices, generics, biologics, biosimilars and drug-device combination For more information related to Evolve Life’s regulatory compliance services, feel free to touch base with us.

Regulatory Services

- Prepare & Submit Regulatory dossiers as per regulatory guidelines.

- Liaising & Following up with Regulatory authorities.

- Consultation of Drug & Device Regulations

- Global Clinical Trials - Regulatory Submissions 

- Comprehensive gap analysis of regulatory data

- Electronic Common Technical Document (eCTD) services , publishing  and                       regulatory authority submission management

- NCEs, NMEs, devices, generics, biologics, biosimilars and drug-device combination

For more information related to Evolve Life’s regulatory compliance services, feel free to touch base with us.

 

Medical Writing

- Concept Sheet preparation for  Abbreviated New Drug Applications (ANDA) submissions

- Protocol writing / Development

                                -  Phase II to IV studies

                                -  Phase I and Patient-based PK studies

                                -  Proof of concept and early phase clinical trials

- Informed consent forms

- Diaries 

- Clinical Study Report

- Clinical and non-clinical sections of the Common Technical Document (CTD) including                 summaries and overviews for EU and US Regulatory Authorities

- Investigator Brochures

- Standard Operating Procedures (SOPs) covering of drug development including

                               -  Design

                               -  Conduct 

                               -  Reporting of clinical trials 

- Concept Sheet preparation for  Abbreviated New Drug Applications (ANDA) submissions - Protocol writing / Development                                 -  Phase II to IV studies                                 -  Phase I and Patient-based PK studies                                 -  Proof of concept and early phase clinical trials - Informed consent forms - Diaries  - Clinical Study Report - Clinical and non-clinical sections of the Common Technical Document (CTD) including                 summaries and overviews for EU and US Regulatory Authorities - Investigator Brochures - Standard Operating Procedures (SOPs) covering of drug development including                                -  Design                                -  Conduct                                 -  Reporting of clinical trials 
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