Solutions at TechnoPharmaSphere

At TechnoPharmaSphere, we offer a comprehensive range of solutions designed to support every phase of drug development, from preclinical research to commercialization.

Our services are tailored to meet the specific needs of each client, ensuring that products are developed efficiently, meet regulatory standards, and reach the market with optimal quality. We focus on providing customized solutions across multiple therapeutic modalities, leveraging our expertise in analytical testing, drug delivery systems, regulatory compliance, and scientific consultation.

Comprehensive Biopharma Solutions

Analytical Laboratory Services

Our contract testing labs provide a variety of analytical services to support all stages of drug development and manufacturing. We offer both non-GMP and GMP-compliant testing, covering:

Method Development and Validation: Creating and validating reliable methods for analyzing active ingredients, excipients, and final products.
Stability Studies: Evaluating product stability under different conditions according to ICH guidelines.
Thermal Analysis: Using techniques like DSC and TGA to assess thermal properties such as melting points and stability.
Mechanical Characterization: Testing properties like hardness and tensile strength to ensure material performance.
Rheological Measurements: Analyzing the flow properties of liquids and semi-solids for product consistency.

Method Development and Forced Degradation

We develop analytical methods using techniques like HPLC, LC/MS, and GC, tailored for specific needs. Our forced degradation studies assess the stability of pharmaceutical compounds under stress conditions (heat, light, pH changes), identifying degradation products and ensuring method robustness.

GMP Analytical Services

Our labs are compliant with Good Manufacturing Practice (GMP) standards, providing essential analytical services for formulation development, excipient compatibility testing, and stability assessments. These services ensure compliance with global regulatory standards.

Biophysical Characterization

We offer comprehensive biomolecular analysis services, including structural elucidation, higher-order structure (HOS) assessment, stability analysis, and identification of biomolecules. Our services ensure thorough characterization under both non-GMP and GMP conditions.

Drug Delivery

Our laboratories focus on enhancing bioavailability, controlling delivery, and formulating targeted drug release formulations. We specialize in drug delivery solutions using lipid nanoparticle technology, offering formulation development, characterization, and optimization services for both non-GMP research and GMP production.

Regulatory support Services

We provide extensive regulatory support services to assist clients in navigating regulatory requirements and preparing submissions for drug approval. From compiling regulatory dossiers to addressing queries, our team ensures compliance with global standards throughout the drug development lifecycle.

Technical Writing Services

In addition to our analytical and drug delivery capabilities, we offer technical writing services to document scientific findings, develop standard operating procedures (SOPs), and prepare regulatory documents. Our skilled technical writers ensure clarity, accuracy, and compliance with industry standards in all documentation.

Scientific Consultation Services

Our scientific consultation services cover a broad spectrum of pharmaceutical and biotechnological areas. We provide tailored guidance in drug delivery, formulation development, and structural elucidation of biomolecules to address specific challenges and optimize drug formulations for enhanced efficacy and stability.

Manufacturing Services

Non-GMP and GMP Manufacturing Services: We offer manufacturing capabilities in both non-GMP and GMP environments to meet diverse client needs. Our processes adhere to the highest quality standards for research purposes or commercial production.
Contract Manufacturing: Our facilities provide clean and sterile processing for batch production and lot release under both non-GMP and GMP conditions. This includes aseptic fill/finish in sterile glass/plastic injection vials.
GMP Process Development: We partner with clients to develop robust manufacturing processes compliant with GMP standards. Our approach ensures clearly defined, documented, and validated processes for consistent quality across all production stages.
Quality Assurance and Control: Our quality management systems uphold GMP guidelines from starting materials to finished products.
Technology Transfer: We facilitate seamless technology transfer for both non-GMP and GMP projects, ensuring effective knowledge transfer to client teams. This includes training on process development and manufacturing techniques for scalable production.

Custom Drug Development Solutions

Tailored Formulation Development: From concept to commercialization, we develop bespoke formulations that optimize the stability, bioavailability, and therapeutic efficacy of small molecules, biologics, and other therapeutic agents.
Advanced Drug Delivery Systems: We specialize in developing cutting-edge drug delivery solutions, such as lipid nanoparticles (LNPs), liposomes, and polymer-based systems, to improve drug targeting and release profiles.
Personalized Therapeutics: We create customized therapies that cater to specific patient populations, ensuring that treatments are not only effective but also safe and targeted.
Cosmetic Formulations: The cosmetic industry demands innovative, stable, and safe formulations that meet high consumer expectations and regulatory guidelines. TechnoPharmaSphere provides customized formulation and analytical services for skincare, haircare, and other personal care products. Our solutions include stability testing, preservative efficacy studies, and compatibility assessments to ensure optimal product performance and shelf-life, aligning with the latest cosmetic trends and science-backed claims.
Cannabis-Based Products: The rapidly evolving cannabis industry requires precise formulation and rigorous quality control to deliver safe, effective, and consistent products. TechnoPharmaSphere specializes in cannabinoid formulation development, including accurate dosing, bioavailability enhancement, and controlled release profiles. We offer tailored solutions for both therapeutic and recreational cannabis products, such as oils, tinctures, edibles, and topicals, ensuring compliance with regulatory standards and market expectations.