Custom Synthesis and API manufacturing

The chemical process development is an art because it is science and at the laboratory, their superior skills begin with their inventive chemists. You’ll notice their chemical experience is quite impressive. The method chemistry team provides sensible solutions for advanced chemical issues based mostly upon in-depth business expertise. Their average chemical development team has worked within the pharmaceutical or scope business for fifteen years. Almost all the team member’s hold a Ph.D. degree and their facilities are the best compared to others and registered with both the agency and DEA.

Team development

Their project managers can guarantee their groups meet the foremost strict timelines using the pliability of multiple resourcing models including Time & Materials, fixed contracts and regular equivalent programs with dedicated resources. Their team has outstanding analytical support as well as in-house NMR (GMP-compliant), multiple LC-MS systems, GC-MS, and over thirty HPLC systems. The team consists of dedicated specialists to help altogether technique development, validation, and impurity identification activities to accelerate your chemical development programs.

Achievements

They have rapidly used a lab-scale method to convert the material from milligrams to multiple kilograms of material whereas, removing pricey chromatography and freeze-drying. They also reduced the number of steps to 6 step custom synthesis with an innovative chemical development synthesis. Develop intellectual property (IP) for a shopper to supply pure compound by straightforward recrystallization. 

The method chemistry team is capable of finding the foremost advanced chemical development problems in a very quick and economical manner. A characteristic feature of their team is the equal balance between skilled method and analytical chemists. They tend to be centered on developing safe, ascendable processes and have a superb record of providing innovative solutions to drug development firms across the world. They provide fully-integrated contract analysis, discovery, and development services as well as Drug Discovery, ADMET-PK, Bioanalysis and method Chemistry & GMP API producing.

Success

Their team is composed of associate degree equal balance between method and analytical chemists World Health Organization work side-by-side to develop safe, scalable, economical and efficient chemical processes. Their broad base of chemical development experience includes:

  • Nucleoside
  • Chiral Resolutions
  • Asymmetric Custom Synthesis
  • Cross-coupling Reactions
  • Stable-labeled Compounds
  • Inorganic Complexes
  • Low-Pressure Reactions
  • Natural product
  • Hydrogenation
  • Carbohydrates
  • Hetero cyclic Chemistry
  • Controlled Substances
  • Biopolymers
  • Chiral Synthesis.

Stability testing support

As of 2011, they have generated over ten process patents for shoppers and enabled over twenty-five IND filings. they’re worked with over sixty-five world clients as well as virtual development organizations, mid-size pharmaceutical companies, biotechs, and high twenty-five pharmaceutical company firms on over 600 comes during a style of arrangements as well as fixed-fee, time & materials, and FTEs. 

The stability testing support is provided to IND, NDA, ANDA, and epitome formulation stability. Stability studies are usually performed at numerous stages underneath storage conditions of various temperatures and humidness.

Physical & Chemical properties

 

  1. Drug and excipient compatibility
  2. Impact of producing method steps
  3. Interactions with packaging materials
  4. Assignment of period time

They perform comprehensive stability studies nearly for each dose type. We tend to support the shoppers at numerous stages of the drug product lifecycle:

  1. Early formulation development
  2. Formulation development
  3. Clinical Supply
  4. The Drug product registration/marketing authorization
  5. Post-approval stability

 

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