New service page - Theta Beta

Technical Solution

ABOUT THE SERVICE DOMAIN

To provide strategic solutions to pharmaceuticals, chemicals, applied sciences industries and the scientific community across the world to resolve their core problems and road blocks. This business model delivers through a team having adequate domain expertise and a dedicated facility.

5+

Years in Service

45+

Long Term Clients

650+

Completed Assignments

20+

Finish Dose
Developments

18+

Process Development Projects Discovery/NCE Projects

85+

Genotoxicity Studies Toxicological Assessments

8+

Pre-formulation
Studies

240+

Q1 Q2 and
Q3 Studies

12+

Sameness and complex Characterization

150+

Critical Impurity Assessments

6+

In-Vitro Model Design and Execution, Comparative Studies

Complete FDF Development Package and Technology Transfer

RLD Characterization Report
Compatibility Study Protocol ad Report
Solubility Study Protocol and Report (wherever applicable).
Analytical Method Development Summary.
Multimedia Dissolution Profiling Protocol and Report (wherever applicable).
Specification and STP (Draft).
Summary of QbD and Optimization (part of PDR).

RLD Characterization Report
Compatibility Study Protocol ad Report
Solubility Study Protocol and Report (wherever applicable).
Analytical Method Development Summary.
Multimedia Dissolution Profiling Protocol and Report (wherever applicable).
Specification and STP (Draft).
Summary of QbD and Optimization (part of PDR).
Results of Reproducibility Batches.
Stability Study Data (In-Use, Hold-Time, Freeze-Thaw, Temperature Cycle, Photostability and Routine Stability).
Analytical Method Validations Protocol ad Report.
Product Development Report.
Pilot Manufacturing and Pilot BE
Pivotal Manufacturing and Pivotal BE

FINISH DOSAGE FORMS

Critical Impurity Assessment

For the unknown and bottleneck impurities, we cater to identify, characterize, isolate, depict pathway of formation which are essential for regulatory submissions and queri

Pre-formulation Studies

Enhancing solubility of an Active, setting up compatibility, screening activities are covered under this. We also cater to 505(b)(ii) activities under milestone models

Critical Method Developments

We have adequate competencies and instrumentation capabilities to support for developing critical methods or to resolve issues related to existing method.

API PSD Determination in FDF

Be it any dosage form; if the Active is in suspended form, we can determine the PSD of that Active using a high resolution microscope and a particle counter.

Q1Q2 and Q3 Studies

We have domain expertise of reverse engineering tasks where we have analytical model as well as complete Q1Q2 support mechanism

API Sameness and Complex Characterization

Our team has executed sameness studies as per FDA guidance documents as well as complex characterization

API AND INTD. PROCESS DEVELOPMENT

API and Advance Intermediate Development and TT

We can execute technology developments for APIs and advance intermediates and their technology transfers.

Resolving Manufacturing and Scale-up Challenges

We have process chemistry and chemical engineering domain expertise to resolve manufacturing challenges.

Cost and Yield Optimization

We undertake projects involving process modifications to reduce cost and improve yield

Critical Method Developments and Assessments

We have adequate competencies and instrumentation capabilities to support for developing critical methods or to resolve issues related to existing method.

Target Molecule Synthesis

We offer services in synthesizing target molecules (organic or organometallic). A well researched execution plan implemented to complete the task.

NCE and Discovery Synthesis

NCE molecule development is one of our core expertise wherein we can cover synthesis activity, toxicological assessments and furthermore formulation developments.

1 Dosage Form Manufacturing

Auto-Coater with PLC; Gansons Compression Machine; Kambert Rapid Mixer Granulator; Gansons Fluid Bed Processor; Gansons Blender; Gansons Blister Pack; Rennessen Packages Lyophilizer; VirTis Autoclave; Equitron Planetary Mixer; Sokany Homogenizer with OHS; Remi Sifter; Sunsai Pharma Capsule filling machine; ANVAY Quadro Co-Mill; ANVAY IPQC Instruments

2 Synthesis Equipments

Fume Hoods Multiple Reaction Assemblies Vacuum Distillation Assemblies Soxhlet Assemblies Vertical Columns Flash Chromatography Pilot Facility

3 Analytical Instruments

HPLCs; Waters (UV, PDA, RI and ELSD) NIR Spectrometer; Bruker KF Titrator; Metrohm Microscope with Particle Classifier; Olympus Franz Diffusion Cell; Logan Analytical Balance; Radwag pH Meter 5-point calibration; Labindia Dissolution Apparatus; Electrolab Preparative HPLCs

4 Stability Chambers

Stability Chamber; Long Term Stability Chamber; Accelerated Stability Chamber; Intermediate Stability Chamber; Standby Photo-Stability Chamber

ASSESSMENTS AND STUDIES

Genotoxicity Study and Assessment

Genotoxicity predictions of structures, toxicological assessments and report writings are covered under this study domain.

In-Vitro Study Design and Execution

We have adequate infrastructure and competency to execute in-vitro studies pertaining to several dosage forms.

Statistical Evaluations

We can execute statistical studies as per FDA regulations and requirements. Also we can statistically predict the shelf life of a product through extrapolating stability data.

Competitor Product Comparison and Assessment

We have mechanism and expertise to execute competitor product comparative study design and execution for marketed products.

Regulatory Supports

Dossier preparation, language translations, market specific regulatory documentations, resolving CMC queries are the activities covered under this category.

Thetabeta

We are committed to leverage scientific research to develop cutting-edge products and commercialize them through efficient business models. Our organization aims to transform innovative ideas into market-ready solutions