We strive to
do our best
AML Group offers worldwide professional medical writing and related services to the pharmaceutical, biotech, medical device and other industries/institutions.
With over 25 years of experience in the field, we strive to be the best possible medical writing and related services.
Our services:
Regulatory writing
We create a wide variety of documents essential for meeting regulatory requirements and submitting necessary materials for biotech researchers and device developers. Examples of common regulatory documents that our writers may either assemble or demystify the process include:
- Standard operating procedure (SOP)
- Literature review and Report
- State of the Art (SotA)
- Acceptance criteria
- Testing and Validation Protocols
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Performance Evaluation Plan (PEP)
- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- Performance Evaluation Report (PER)
- Clinical Investigation Plans and Reports for clinical trials
- Post Market Surveillance (PMS) Plan
- Periodic Safety Update Report (PSUR) / PMS Report
- Post Market Clinical Follow up (PMCF) Plan/Report
- Summary of Safety and Clinical Performance (SSCP)
- Risk Management file
- Biological Evaluation Plan (BEP)/Report (BER)
- Human factors engineering (HFE) and Usability Engineering Report (UER)
- Labelling and instructions for use (IFU)
Medical writing
Different benefits
Initiation
Project scope identification Omnis eum faccatur magnis mo odisitae cume occabores niatem laut ad moluptatium
Planning
Project scope identification Omnis eum faccatur magnis mo odisitae cume occabores niatem laut ad moluptatium
Monitoring & control
Project scope identification Omnis eum faccatur magnis
Execution
Project scope identification Omnis eum faccatur magnis Dmnis eum faccatur magnis Ymnis eum faccatur
Closure
Project scope identification Omnis eum faccatur magnis Dmnis eum faccatur magnis Ymnis eum faccatur
Initiation
Project scope identification Omnis eum faccatur magnis mo odisitae cume occabores niatem laut ad moluptatium
Planning
Project scope identification Omnis eum faccatur magnis mo odisitae cume occabores niatem laut ad moluptatium
Monitoring & control
Project scope identification Omnis eum faccatur magnis
Execution
Project scope identification Omnis eum faccatur magnis Dmnis eum faccatur magnis Ymnis eum faccatur
Closure
Project scope identification Omnis eum faccatur magnis Dmnis eum faccatur magnis Ymnis eum faccatur