Pro-active Consulting Inc. provides translation services covering a wide range of subjects specializing in medicine and pharmaceutical areas.
Medical field
| Section | Types of Medical Documents |
|---|---|
| CMC | (API & Drug products) Documents of Test Procedures and Acceptance Criteria (API & Drug Products) Stability Test Report Certificate of Analysis (COA) Documents of GMP Process Control such as DQ, IQ, OQ and PQ Other items required for CTD or IMPD Documents |
| Nonclinical Studies | Pharmacology Study Report (including Safety Pharmacology Study) Toxicity Study Report ADME Report Report Documents related to other Nonclinical Studies |
| Clinical Trials | Investigator’s Brochure (IB) Protocols Informed Consent Form Clinical Study Reports (CSR) Case Report Form (CRF) Report Documents related to other Clinical Studies |
| Pharmaceutical Affairs | Common Technical Document (CTD) Annual Report Pharmaceutical Regulations and the related documentation Guidelines |
| Documentation for GxP | GMP, GQP, Quality Manuals, SOP, Other documents |
| Post Marketing Surveillance Documentation | Package insert and Instructions for use Labels CIOMS Post Marketing Product Surveillance Documents, Reports Literature Documentation PSUR |
| Cosmetics, Supplements and Medical devices | Brochures, Other Related Documents |
| Medicine-Related Patent | Patent Publication, Patent Specification |
| Other | MSDS |
Corporate Management, Economy
| Section | Types of Documents |
|---|---|
| Financial Data | Annual Reports Financial Statements Annual Securities Reports M&A Related documents |
| Management | Press Release Business Reports Audit Reports Company Brochure Training Materials Presentation Materials Business Letters |
