TOU PHARMA BIO is one of the well-respected and prominent Regulatory Consulting Organization for the Pharma bio-sciences industry. It was founded by visionary Dr. Habibuddin M Ph.D. (Pharmacy). TOU PHARMA BIO is the pioneer Regulatory Organization for assisting in regulatory compliance of healthcare products such as Pharmaceuticals, API, Biologicals, Herbals, Nutraceuticals, Phytochemicals, Medical devices. Most importantly, TOU PHARMA BIO is designed to support the Pharmaceutical Industry, Pharmaceutical profession and continuing education toward regulatory affairs.
Enabling life sciences organizations to meet their Regulatory goals across the globe for Pharma, Generics, Biosimilars, Vaccines, Cosmetics, OTC, Nutraceuticals/Food and Dietary Supplements, and Medical Devices, Tou Pharma Bio offers a full spectrum of end-to-end Regulatory services that span across a strategy to submissions and lifecycle maintenance.
Out sourcing
To reduce investment level.
- Frequent changes or updates need to install.will attract significant cost of up to 20% of software billing amount.
- Specialized systems require trained manpower, companies need have to shell out extra bit of money on training existing staff with new systems or look to hire trained experts
- Payback period on the investment can be very lengthy for Small companies who have less than 10 submissions annually.
- Outsourcing has been the BUZZ word , with so many companies outsourcing many processes to cross countries, cities and within cities also. Outsourcing has always helped in reducing 2 things
"TIME & MONEY"
It is logical to outsource, companies can concentrate on their core competency, in the case of eCTD outsourcing, it ticks all the right boxes Logical, Money and time saving.
- 1) No need to make any upfront investment in the technology, you are only paying for the service in short you are only paying for manpower thereby saving a lot of capital which can be used for R & D activity.
- 2) No Need to worry about breakdowns and heavy Annual Maintenance contracts and frequent FDA updates on the systems so it’s a big plus over there.
- 3) Outsourcing works on Pay as you go basis so you are paying only for actual submission you make in a year so if you don’t plan any submission you don’t pay anything.
- 4) No need to train or hire eCTD experts in your company reducing your company’s permanent employees and saving on HR expenditure. Companies with less than 10 submissions in a year will be the biggest beneficiary of this model.
Services
- Global Market Analysis
- Regulatory Consultation
- Market Access and Regulatory Strategy
- Regulatory Intelligence
- Publishing and Submissions
- Regulatory Labeling
- Artwork and Pack Management
- Regulatory Medical Writing
- Safety and Pharmacovigilance
- Audit and Validation
- Health Authority Interaction
- Product Registrations and Market Authorizations
- Lifecycle Management/Post Approval Activities
- Local on-the-ground Presence
- Regulatory Centralization