Integrated Product Development

• New Chemical Entities (NCEs): Expertise in the development of innovative compounds, ensuring compliance with regulatory standards from initial concept to market launch.
• Late Phase Product Development: Support for products in late-stage clinical trials, optimizing strategies for successful transition to commercialization.
• Over-the-Counter (OTC) Products: Development of non-prescription products with an emphasis on safety, efficacy, and regulatory compliance.

Strategic Planning

• Clear Development Strategies: We create actionable and executable strategies for efficient product development, aligning with market needs and regulatory requirements.

Regulatory Support

Dossier Preparation

• CTD/ACTD Format: Preparation of comprehensive dossiers in Common Technical Document (CTD) and ASEAN Common Technical Dossier (ACTD) formats, ensuring compliance with international regulations.
• Compilation and Review: Thorough compilation and review of dossiers according to CTD, ACTD, and specific country requirements.

Regional Guidelines

• Compliance with Global Standards: Guidance for product development and regulatory submissions in East & West Africa, CIS, Latin America, and Asian countries.

Legal and Regulatory Applications

• Legal Application Management: Assistance with applications for Certificate of Pharmaceutical Product (COPP), product permissions, Free Sale Certificates (FSC), and other necessary documentation.
• Post-Approval Support: Comprehensive support for post-approval queries until registration is obtained, including renewal, retention, and variation applications.

Clinical and Non-Clinical Dossiers

• Module 4 & 5 Preparation: Development of clinical and non-clinical modules, ensuring alignment with regulatory expectations and scientific rigor.
• Drug Master File (DMF): Preparation of DMFs to provide detailed information about the manufacturing and control of drug substances.

Advanced Submission Formats

• eCTD Guidelines Compliance: Compilation of dossiers according to the latest eCTD guidelines for select countries and preparation of Abbreviated New Drug Applications (ANDAs).

Labeling and Artwork

• Artwork Preparation: Comprehensive support for labeling and artwork preparation, ensuring compliance with regulatory requirements and market preferences.

By leveraging our extensive experience and comprehensive services, we aim to support clients in navigating the complexities of product development and regulatory compliance, ultimately facilitating successful market entry and sustainability.

Our state-of-the-art manufacturing equipment ensures efficient and high-quality production processes:

• Vibratory Sifter: For accurate particle size separation and product consistency.
• Rapid Mixer Granulator: Efficient mixing and granulation for uniform product formulation.
• Rapid Dryer: Quick drying of granules, enhancing productivity.
• Multi-Mill: Versatile milling for size reduction of various materials.
• Co-Mill: Precise milling and granulation for controlled particle size.
• Blenders:
  1. Octagonal Blender: For gentle blending of powders with minimal segregation.
  2. V-Shaped Blender: Ensures homogenous mixing of bulk materials.
• Tablet Compression Machine: For efficient tablet formation with adjustable pressure and speed.
• Bilayer Tablet Compression Machine: Allows the production of bilayer tablets for controlled release formulations.
• Mini-Fluid Bed Granulator: Compact solution for granulating small batch sizes.
• Bottom Spray Fluid Bed Processor: For uniform coating and drying of granules.
• Auto-Coater for Tablets: Automated system for coating tablets with precision.
• Blister Packing Machine: Efficient packaging solution for tablets and capsules.
• Leak Test Apparatus: Ensures the integrity of packaging by detecting leaks.
• Semi-Induction Cap Sealing Machine: Provides tamper-evident seals for containers.

Quality Control Equipment

Our quality control instruments guarantee the safety and efficacy of products:

• Sieve Shaker: For particle size analysis to ensure uniformity in formulations.
• Tap Density Tester: Measures the bulk density of powders.
• Disintegration Apparatus: Tests the disintegration time of tablets to ensure proper release.
• Moisture Analyzer: Accurately determines moisture content in raw materials and finished products.
• High-Speed Homogenizer: For effective blending and emulsification of formulations.

Sterilization Equipment

We utilize advanced sterilization technologies to ensure product safety:

• Autoclave: Steam sterilization of equipment and materials.
• Dry Heat Sterilizer: Effective method for sterilizing heat-stable products.
• Lyophilizer: For freeze-drying products, enhancing stability and shelf life.

Laboratory Instruments

Our laboratory equipment supports rigorous analytical testing:

• Laminar Air Flow Station: Provides a sterile environment for product handling and preparation.
• Bio-Safety Cabinet: Ensures safe handling of hazardous materials.
• Analytical Instruments:
  1. HPLC (High-Performance Liquid Chromatography): For precise separation and quantification of compounds.
  2. GC (Gas Chromatography): For volatile compound analysis.
  3. IR (Infrared Spectroscopy): For functional group identification and analysis.
  4. IC (Ion Chromatography): For detecting ionic species in solutions.
  5. UV Spectrophotometer: For quantitative analysis based on light absorption.
• Dissolution Apparatus: Tests the dissolution rate of solid dosage forms.
• Polarimeter: Measures optical rotation of solutions for concentration determination.
• Kjeldahl Apparatus: For nitrogen content analysis in organic compounds.
• Viscometer: Measures the viscosity of liquids for formulation consistency.
• Osmolarity Meter: Determines the osmolarity of solutions for various applications.
• pH Meter: Accurate measurement of pH for quality control.

By integrating advanced manufacturing and analytical equipment, we ensure high-quality production and thorough testing of pharmaceutical and nutraceutical products.