Formulations
Formulation Products
Our state- of- art laboratories and expertise are designed to offer an extensive range of formulation services to meet customer needs. With technology and a distinctive and clinical approach we provide a range of formulations. A highly professional regulatory affairs team is in place to execute as per market demands.
For formulation enquiry please contact:
Dr. Vijaysinh Chauhan
[email protected]
Formulation R & D
Dossier Development
THINQ Pharma-CRO Limited is engaged in Dossier Development for highly regulated markets like US, EU, Australia, New Zealand, South Africa, Brazil, Mexico and emerging market like Commonwealth of Independent States (CIS countries), Latin America and MENA Countries (Middle East and North Africa). The scope of work for Dossier Submission includes API Sourcing, API Characterization, Formulation Research & Development, Analytical Research & Development, Packaging development, Scale up and Exhibit batch Manufacture, Stability Studies, Technology Transfer and Documentation.
Formulation Research and Development @ THINQ Pharma-CRO Limited Research
Core Competencies
THINQ Pharma-CRO Limited undertakes contract formulation development of Generic (Prescription & OTC), NCEs and proof of concept products (505(b)2 & Hybrid) of various dosage forms, aided by state-of-the-art technology and equipment. Formulation designs include:
- To develop proof of concept and create position by proactively patenting technology
- Ethical Products
- Veterinary Products
- Efficient Project Management
- To develop non-infringing (NIF) strategies, patent drafting, filing and coordinating with IP agents and attorneys
Scope of Work
- Literature Information & Primary Patent Status Evaluation landscaping and development strategy.
- Prototype Formulation Development in compliance with latest regulatory guidance such as ICH Q8 QbD.
- Packaging Development
- Scale-up of selected Prototype Formulation
- Process Optimization through QbD (ICH Q8)
- Process Validation
- Manufacture of Exhibit/Bio-batch
- Bioequivalence Study
- Product Development Report
- Documentation in CTD Format
- Technology Transfer
- Stability Study
- GLP facility to support your R&D needs
- Photo stability with humidity chamber
- Characterization of API, Excipients and Drug Product
- Dissolution Profiling
- Residual Solvents analysis in API and Drug Products Contract
- Stability Services as per ICH guideline
- Stability Indicating Method
- Development and Method Validation
- Stability Protocol Preparation, Analysis & Monitoring
- Assigning Shelf-life
International Regulatory Affairs @ THINQ Pharma-CRO Limited Research
Our Service includes Developing Regulatory Strategies, Comprehensive Documentation, Submission and Archiving of Documents. Regulatory Department also oversees the compliance program, ensuring that all practices conform to the constantly changing regulatory requirements.
Core Competencies
- Preparation and Submission of Drug Master File (DMF)
- Preparation of Site Master File (SMF)
- Generation of Dossier as per European Union and US Guidelines
- Pre-Inspection Audit
- Assistance for getting Certificate of Suitability (CoS)
- Reply to Queries
- Writing Expert Reports
Quality Assurance @ THINQ Pharma-CRO Limited Research
A dedicated QA team ensures world class quality by continual upgradation in systems. All our R&D activities navigated by QA procedures. The Scope of work covers the following:
- Document management system
- Standard Operating Procedure
- Customer meeting and training programme
- Change Control System
- Self-inspection
- Qualifications
- Review and evaluations of Master Formula Card, Validation Protocols and Reports.
- All necessary controls on starting raw materials, intermediate products, bulk products, in-process quality controls, calibrations and validations.
- Safety policy
- Environment policy
Infrastructure @ THINQ Pharma-CRO Limited Research
THINQ Pharma-CRO Limited India:
Total Floor Area: Approx 5000 sq. feet ,Brooklyn Tower 11th floor.
- Formulation and Development: 2000 sq. feet
- Analytical Development: 2000 sq. feet
- Regulatory Affairs, DQA and IPR: 500 sq. feet
- Support Services – HR/Admin/IT: 500sq. feet
Infrastructure: Formulation Development @ THINQ Pharma-CRO Limited Research
The Formulation Development Laboratory has all the modern equipment that are required for product development study. THINQ Pharma-CRO Limited is committed to regularly upgrade the existing technology available by procuring latest Instruments and Equipment available in the market.
The Formulation Development lab has the following equipment:
- Mechanical Sifter
- Rapid Mixer
- Granulator
- Fluid Bed Dryer
- Fluid Bed Processor (with bottom spray)
- Comill
- Cage/Octagonal Blender
- Rotary Compression Machine – GMP Model
- Auto Coater
- Reverse Laminar Air Flow
- Stability Chambers
- Photostability chamber with Humidity control
- Planetary Mixer
- Mechanical Stirrer and Homogenizer
- Sieve Analyser
- Halogen Moisture Analyzer
- Disintegration tester
- Friability test apparatus
- Hardness Tester
- Capsule filling machine
- Autoclave
Infrastructure: Analytical Development @ THINQ Pharma-CRO Limited Research
The Analytical Development Laboratory has all the mandatory requirements. It complies with the cGLP.
The Analytical Development lab has the following equipment:
- High Performance Liquid Chromatograph with Auto sampler, Quaternary gradient, Diode array, UV, Fluorescence and Refractive index detector
- Gas Chromatograph with Head Space
- Dissolution Apparatus with Auto Sampler and UV Spectrophotometer
- Dissolution media degasser
- UV/Vis Spectrophotometer
- Fourier Transform IR Spectrophotometer
- Digital Analytical Balances with varied capacity
- Auto Titrator
- Sample Dilutor
- Water Purification System
- TLC Spotter
- BOD Incubator
- Autoclave
- Laminar Air Flow
- Viscometer
- Melting Point Apparatus
Infrastructure: Database and IT @ THINQ Pharma-CRO Limited Research
The Formulation Development, Analytical Development and Regulatory Affairs are well-connected with the recent progress of each and every product through LAN. There is an internal ERP programme and an Internal Software programme describing the stage, timelines and constraints of each and every project. Periodic meeting is held during which the project status is discussed.
Each and every Project can be accessed easily through E-mail for knowing the progress of the Projects.
Our dossiers can be viewed on the web for evaluation upon request.
Infrastructure: Facilities – Tie ups @ THINQ Pharma-CRO Limited Research
Facilities
We, at THINQ Pharma-CRO Limited believe that Quality is built up in the product at various stages, right from the API sourcing to the submission. Though we are a Pharma CRO we involve ourselves in all the area related to Pharmaceutical products. We feel our search in achieving quality product is not restricted to Product and Analytical Development, so we have joined hands with the best quality counter-parts like API Manufacturers, Contract Manufacturers and Clinical CROs. After all “TOGETHER WE CAN SERVE THE BEST”.
Tie-up with API Suppliers
We have tie-up with leading Bulk Drug Manufacturers in India. Our tie-up is not only with Indian Manufacturers but also with some International API Manufacturers.
Tie-up with Clinical CRO
We have an association with one of the leading clinical CROs involved in conducting BA/BE Study. It is ANVISA approved and has a team of highly experienced Medical Professionals.
Generic Formulation,
Manufacturing and Marketing
Formulation Products
We have a cGMP compliant R&D facility for formulation manufacturing, testing and development. We also have the competency to develop formulations along with requisite BA/BE studies, regulatory services and filing of the ANDAs. We also contract manufacture the developed formulations for US and ROW markets. Our present reach of marketing formulations spreads across Singapore, Malaysia and South Africa and various other countries through partnerships.
We have already achieved 12% market share in a majority of the launched products and more than 35% to 50% market share in other niche products. The generic formulations manufactured by Indian manufacturers are marketed by THINQ/RISING under exclusive marketing agreements in the US market. Currently we have more than a dozen prescription products being sold under our label in the U.S. market and more than 30 products are under development.
With extensive knowledge of pharmaceutical ingredients over the past 3 decades we have acquired the ability to develop complex chemistry. In the past, we have had Mr. Robert Grubbs, a renowned Nobel Laureate, on our Technical Board.
We have worked with major MNCs, including Japanese companies developing CRAMs and intermediates with complicated technology.