THinc is a company of regulatory affairs, medical writing, and nonclinical safety professionals with a proven track record of success in the pharmaceutical industry. THinc was established as a privately held consulting firm in 1995 to expedite the development and approval of new medicines. Our clientele range from emerging, privately held biopharmaceutical companies to Fortune 500 pharmaceutical companies.
Newsreel - What's New at THinc
NEW SERVICE - Clinical Operations
THinc now offers monitoring and management of clinical trial study sites and CROs. THinc can also assist with auditing of legacy documentation and safety databases.
Recent Assignments FY 2012 - Gap Analyses and Strategies
- Gap analyses—Advised clients on development of nonclinical, clinical, CMC, and regulatory strategies for a new chemical entity (NCE) in Crohn’s disease; evaluated the regulatory path for product to treat End Stage Renal Disease (ESRD)
- Strategic plans—Strategized with clients on development plans for products in attention deficit disorder (ADD), multiple sclerosis (MS), complex regional pain syndrome (CRPS), Chronic Kidney Disease (CKD), and ESRD; developed strategies to address Clinical Hold; worked on post-approval CMC changes
Recent Assignments FY 2012 - Regulatory Documents
- Original IND submission—Wrote CTD summaries, Module 1, and Module 3 in rheumatoid arthritis (RA)
- pre-IND meeting packages—Contributed to development of packages in RA, fixed-dose combination antibiotic and combination product (device), CKD, and ESRD
- EOP2 meeting packages—Contributed to development of packages in chronic lymphocytic leukemia (CLL), dry eye, gout, mantle cell lymphoma (MCL)
- Scientific Advice Working Party Briefing Document (SAWP)—Contributed to meeting package in irritable bowel syndrome (IBS)
- CMC section of NDA—Provided regulatory guidance and review in acute bacterial skin and skin structure infections (NCE parenteral dosage form); wrote drug substance and drug product process development reports; prepared multiple nonclinical and CMC IND amendments in various indications
- RX-to-OTC switch—Wrote nonclinical and regulatory sections for a European submission in fungal infections
- DSURs and Annual Reports (ARs)—Project managed and wrote DSURs and ARs in cancer and IBS
Recent Assignments FY 2012 - Interactions with Agencies and Regulatory Meetings
- Prepared clients for and acted as the US regulatory agent at five FDA meetings
- Acted as clinical safety representation at SAWP meeting with EMA
Recent Assignments FY 2012 - Scientific Communication
- AMWA Annual Meeting— Presented on key aspects of regulatory affairs to scientific writers
- Contributed to two scientific articles
- Prepared conference posters
Recent Assignments FY 2012 - Clinical Operations/Writing
- Monitored and managed study sites and CROs for multiple cancer trials
- Audited legacy safety database
- Assembled appendices for ICH-compliant clinical study reports
- Wrote Investigator Brochures for cancer and IBS products
Recent Assignments FY 2012 - Regulatory Operations
- Processed original CTD IND submissions
- Provided IND maintenance in cancer, RA, and IBS
