Eternus Global Pharma KPO is the answer.
You have a good pharmaceutical product, but you want to test its safety and efficacy. Eternus Global is ready to assist you in every step of the way from concept to marketing.
You already have an idea but you don’t know how to start. Eternus Global offers medical research services that gather all relevant studies and clinical trial reports that are relevant to your area of interest. We offer evidence-based data which can help predict your compound’s safety and efficacy as well as its market potential and licensing requirements. We also offer regulatory and importation/exportation consulting.
Does your investigational product lack animal studies? We can find an animal research center for you and assist you in compiling evidence in terms of safety and efficacy of your product.
Now that you have proven that your product is safe and effective in animals, the next step is to test it among humans. Phase I involves studying pharmacokinetics particularly oral bioavailability and half-life of the drug. It also tests the drug in healthy individuals for dose ranging. Eternus Global can help you design Phase I clinical trials and write protocols and study reports.
After this, the drug undergoes Phase II testing, which involves testing of the drug on patients to assess efficacy and safety. Phase III involves testing of the drug on a group of patients (1000-2000) with the target disease to assess efficacy, effectiveness and safety. Again, Eternus Global can help you in the research design, planning and writing protocols and study reports, as well as statistical analysis.
We can assist you in marketing and advertising your products. We can do market analysis, segmentation and targeting offline and online. We can also write marketing copy for your products.
After your drug is approved, it should undergo post-marketing surveillance. We can assist you in compiling adverse events and in performing further research.
pharma regulatory writing
Eternus Global offers medical writing services for pharmaceutical companies, medical practitioners, students, researchers, and contract research organisations. We have expert knowledge and experience on the pharmaceutical industry, clinical research organizations, and academia.
Our pharma regulatory writing services include:
- Clinical Trial Protocol Writing
- Clinical Trial Manuscript Writing
- Pharmaceutical or food supplement product review and research
- Journal/conference submission
- Medical marketing reviews and reports
- ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV
- Investigator Brochures
- Case Report Form (CRFs)
- Patient information including Informed Consent and Patient Brochures
- Standard Operating Procedures (SOPs)
- Statistical analysis/ Biostatistics
Pharma Regulatory Services
We take pride in quality and secure work. Our pharma regulatory services not only ensure that you comply with local laws, Philippine Food and Drug Administration regulations and industry practices; it also maintains strict confidentiality. We take pride in assisting businesses which aim to provide safe and effective healthcare products to consumers in the Philippines.
Our Pharma Regulatory Services include processing on the following documents:
License to Operate (LTO)
- LTO as Drug, Cosmetics, Household Hazardous Substances, Food, Medical Device Importer and Distributor
- LTO as Drug Re-packer with Certificate of Good Manufacturing Practice (CGMP)
- Medical Supplies
- Medical devices
- Cosmetics and household hazardous products
Before registration, we meet with you to discuss your needs, put together and review product dossiers and furnish regulatory submission process. In case you are aiming to market your product within the Philippines, we will work with you and create a marketing strategy for your product (portfolio).
The FDA is also accountable for the approval and monitoring of clinical trials within the Philippines. Companies wishing to introduce new and progressive products have to first register with FDA, after which they are going to be granted a temporary CPR to use for the medical trial, which then requires standard reporting.
Eternus Global Pharma Regulatory Services
Eternus Global Company KPO can assist your organization in processing and obtaining LTOs and CPRs from FDA, while also offering services for pharmaceutical traders and entrepreneurs who want to do business within the Philippines.