Product and Services
Custom Synthesis OF Impurities for SMALL MOLECULES AND PEPTIDES
Our scientists are well trained to design and synthesize difficult-to-make, complex organic compounds using cutting edge technologies and methods with multi steps, ranging from milligrams to kilograms.
We also have a dedicated planning team consisting of well experienced Synthetic Organic Chemists who have extensive experience in cost effective synthesis route scouting, process development and optimization through DoE and QbD.
- Our team of Synthetic Organic chemists with in-depth knowledge and experience in complex organic synthesis encompassing a wide range of compounds, including prostaglandins, alkaloids, steroids, terpenoids, peptides, and more.
- We offer services on synthesis of all kinds of bioactive molecules such as alkaloids, terpenoids, steroids, heterocyclic compound, carbohydrate based compounds, antibiotics etc.
- Semaglutide
- Liraglutide
- Terzepatide
- Raw Material Intermediates
- Main chain,sidechain and its Fragments
- Short Peptides
- PEG Linkers
ISOLATION AND PURIFICATION SERVICES
we offer specialized Isolation and Purification services to obtain high-purity compounds from complex mixtures.
Our skilled team of experts utilizes a range of advanced techniques and methodologies to isolate target compounds from various sources, including natural extracts, reaction mixtures, and impure samples. The isolation and purification process ensures the production of high-quality substances required for research, development, and commercial applications.
Reference listed Drug (RLD) products procurement
Buraaq plays a vital role in the global supply chain of Reference Listed Drugs for the pharmaceutical companies conducting clinical trials, CRO, and Sponsors. We supply innovator drugs, Comparator Drugs, and Reference Listed Drugs (rld pharmaceutical) for bioequivalence studies and Comparator sourcing for clinical trials from the US, EU, UK, Australia, Canada, Brazil, Malaysia, Japan, and other major countries.
Buraaq carries rich experience and immense knowledge of the regulatory needs of each country for strategic comparator sourcing and sourcing various products with validated and reliable global partners. We have a fully audited supply chain with traceable supply partners who possess vast experience for the successful delivery of cold chain products, hard-to-source products, specialty product lines, or hospital lines supplies across the globe.
The term “Managed Access Programs” (“MAPs”) covers various types of programs, in particular “Compassionate Use”, “Expanded Access”, “Named Patient Supply”, “Named Patient Program”, “Special Access Schemes/Programs”, “Autorisations temporaires d’utilisation (ATU)” and others.
It is another way of obtaining medicine before authorization where a doctor requests supply of an unauthorized medicine directly from the manufacturer to treat an individual patient under the doctor’s direct responsibility.
Global Clinical Supplies
- Smart sourcing solutions that ensure clinical trial spend within a budget
- World wide access to medicines and ancillaries, directly from global network of manufacturers and validated third party suppliers
- Technical guidance and consultancy with support from our experts, including physicians, Qualified Persons, and in-house regulatory department
- Global distribution, Global Clinical Supply and logistics capabilities shipping to over 35 countries. Whether your product is ambient, controlled room temperature our global supply chain ensures the medicine gets to sites quickly and safely
- Our deep knowledge of the products we are sourcing and the clinical and/or commercial supply chains required, including Ancillary Supplies for Clinical Trials, further allows us to provide clients with a strategic and advisory approach in cl
PHASE I to PHASE IV CLINICAL TRIALS SUPPORT
Clinical Trial Supplies
Comparator Drug and Ancillary Sourcing Supplies
Warehousing and Global Distribution
Returns, Reconciliation and Destruction
API and intermediate synthesis r&d TO COMMERCIAL
Intermediates play a vital role in API synthesis by enabling controlled modifications for desired chemical properties. They represent various stages in the synthesis pathway toward the API, contributing significantly to the efficiency, scalability, and quality of the synthesis process. Well-designed intermediates can simplify complex routes, enhance yield, and reduce costs.
- Key Intermediates
- Protecting Group Intermediates
- Salt Formation Intermediates
- Chiral Intermediates
Pharmaceutical intermediates are subject to GMP guidelines for quality control, compelling manufacturers to establish appropriate systems and processes. To ensure safety and quality, they must identify and control synthesis-related impurities as regulatory authorities require.
Process validation is necessary to maintain consistent quality in manufacturing, with manufacturers obliged to demonstrate process capability to meet specified standards. Additionally, comprehensive documentation is vital
PROCESS DEVELOPMENT
we offer comprehensive Process Development services to support the efficient and scalable production of chemicals, intermediates, APIs, and other compounds.
Our Process Development team comprises experienced chemists and engineers who work collaboratively to optimize synthetic routes, streamline processes, and ensure the successful transfer of laboratory-scale reactions to commercial production
REACTION CAPABILITIES
- Hydrogenation
- Epoxidation
- Hydrolysis
- Nitration
- Sulphonation
- Halogenation
- Autoclave Reactions
- Oxidation
- Condensation
- Cyclization
- Alkylation/Acylation
- Various Named Reactions
- Various Rearrangements
- Chiral asymmetric Synthesis
- Reduction
Custom formulAtion services
PROCESS CAPABILITIES
- • Headspace oxygen analyser
- • Osmometer/pH meter
- • Dissolved oxygen meter
- • Terminal sterilization
- • Multi-magnetic stirrer
- • Laminar Airflow
- • Single-use bags for handling cytotoxic
- substances
- • Lyophilizer – 25L/Genesis –Pilot scale
- • Ampoule filling and sealing machine
Formulation
- Pre-formulation Profiling and Drug-ability Assessment Formulation Development (NDA/ANDA)
- FIH Studies and Various Clinical Phases
- Pre-clinical Formulation Development
- Life Cycle Management (LCM/NDDS)
Services
- Extractable and Leachable studies
- Delamination studies
- Filter membrane validation studies
- D-Value determination studies
- Elemental impurities testing
- Nitrosamine testing and validation
Why buraaq
- R&D is capable of producing milligrams to multi-kilogram quantities of complex organic compounds through good documentation and recording practices.
- Qbd-Based product development for regulatory market registration
- Designing drug products with 505b(2) strategy within acceptable regulatory and proprietary limitations
- Customizable services based on client needs product development to commercial supply
- Dedicative project execution experts for each client to support product development
Commitment to quality
We understand the critical importance of accuracy, precision, and reliability in the field of synthetic organic chemistry majorly focused on providing cutting-edge reference standards complying with pharmacopeial guidelines and regulations.
Our dedication to maintaining the highest standards is evident throughout our processes, services, and interactions with clients.
We are ISO 9001:2015 a accredited synthesis lab.
EXPERIENCED TEAM
Our team combines experience and young talent, ensuring organized efforts for timely and high-purity deliveries
