Innovate and Succeed
SDR is Your Comprehensive Resource &
Partner in Pharmaceutical R&D,
Production, and Consulting
Navigating Your Journey from Concept to Market
Our Services
Formula Creation, Enhancement
and Development
I. Creation of Well-Studied and Accurate Formulations
As a premier pharmaceutical R&D company, we excel in delivering comprehensive formula creation, enhancement and development services to manufacturing companies worldwide. Our specialization lies in developing well-studied, accurate formulas that meet the exact specifications of global benchmark products. Our unwavering commitment to excellence ensures that our clients receive products of the highest standards, marked by innovative quality and unparalleled effectiveness.
II. Formula Matching and Analysis
Our process involves meticulous analysis of benchmark products to create formulas that guarantee identical efficiency and effectiveness. This precise approach ensures that the products we develop for our clients not only meet but often exceed the performance of similar global products. Our attention to detail guarantees that the formulas we provide are indistinguishable in efficacy and effectiveness from the industry benchmarks.
III. Achieving Optimal Dissolution Profiles
A critical element of pharmaceutical development is achieving the ideal dissolution profile, which significantly impacts the product’s bioavailability and so therapeutic efficacy. Our team of experts meticulously designs and tests formulations to optimize the dissolution profile, ensuring that active ingredients are released at the desired rate and duration, thereby accomplishing therapeutic benefits.
IV. Bioequivalence Tests Pass Guarantee
We recognize the critical importance of bioequivalence in the pharmaceutical industry, where products must demonstrate similar bioavailability to benchmark products. Our rigorous testing and development protocols ensure that the products we formulate pass stringent bioequivalence tests. This guarantees our clients the confidence that their products will deliver consistent, intended therapeutic outcomes, and so, their products will be approved by authorities of Medicines and Healthcare products.
Integrated Solutions & Industrialization
From Concept to Completion
I.Preparing the C.T.D. File
We begin by meticulously preparing the C.T.D. (Common Technical Document) file for your product. This essential documentation outlines the necessary information for regulatory submissions, ensuring that your product meets all required standards and facilitates a smooth approval process.
II. Specifications and Raw Material Analysis
Our team selects the critical specifications for raw materials and determines the methods of their analysis. We review the certificates of analysis for each ingredient and provide recommendations to ensure that all materials comply the required specifications and suit the intended products.
III. Supplier Document Review
Our experts review supplier documents and offer recommendations to ensure that all materials and processes align with regulatory requirements and quality expectations, enhancing the overall reliability and integrity of your product.
IV. Comprehensive C.T.D. File Management
SDR oversees every stage of the C.T.D. file application and implementation, meticulously guiding the process from initial submission to the final product. We ensure that the formula meets all global standards through rigorous physical, chemical, and stability tests, resulting in a product that mirrors the highest industry benchmarks.
V. Document Provision and Team Training
We provide all necessary documentation in the required formats during manufacturing to maintain consistency and accuracy. Additionally, we offer comprehensive training for your team to ensure they are well-versed in the product development process, supporting them to achieve and maintain the highest quality standards.
VI. Manufacturing Process Supervision
SDR supervises the development of the manufacturing process, tailored to the equipment and capabilities available in your facility. We review each manufacturing step, oversee stability studies, and provide actionable recommendations to optimize production efficiency and product quality.
VII. Packaging Material Recommendations
We offer expert recommendations on suitable packaging materials to ensure that your product is presented in the best possible manner, enhancing its market appeal and maintaining its quality throughout its lifecycle.
VIII. Marketing Presentation Oversight
SDR also supervises the marketing presentation of your product, ensuring that it is effectively promoted and aligns with industry standards. Our guidance helps to position your product successfully in the marketplace, maximizing its impact and reach.
Expert Consultants for Established Products
and Manufacturing Processes
I. Problem Resolution & Development of a Dedicated Manufacturing Process
As a premier pharmaceutical R&D company, we excel in delivering comprehensive formula creation, enhancement and development services to manufacturing companies worldwide. Our specialization lies in developing well-studied, accurate formulas that meet the exact specifications of global benchmark products. Our unwavering commitment to excellence ensures that our clients receive products of the highest standards, marked by innovative quality and unparalleled effectiveness.
II. Staff Support and Training
We offer extensive support to your production teams, ensuring they adhere to best manufacturing practices. For companies with existing R&D departments, we provide specialized training in formula development processes. This training reinforces best practices, boosts team expertise, and helps maintain consistently high production quality.
III. Process Optimization and Cost Reduction
Our services go beyond mere problem-solving. We perform in-depth analyses of your manufacturing processes to identify opportunities for cost reduction. By suggesting strategic adjustments to formulas and production methods, we help you lower production costs while upholding the highest quality standards.
