Pharma Contract Services companies provide services on contract basis to other companies in the pharmaceutical industry from drug development through drug manufacturing. The outsourced contract services helps the pharma companies to concentrate on their core competencies by minimizing overhead involved in terms of additional technical resources and infrastructure.
The various pharma contract services include : Stability Studies , Formulation Development Services, Analytical Methods Development and Validation, Clinical Research Services, Process Development & Scale-Up Services, Process Validation Services, Regulatory Affairs Services, Analytical Laboratory Services etc.,
Stability Studies / Testing:
Stability testing is the key procedural component in the pharmaceutical development program for a new drug as well as new formulation. Stability testing evaluates the effect of environmental factors on the quality of the drug substance or a formulated product which is utilized for prediction of its shelf life, determine proper storage conditions and suggest labeling instructions.
Depending upon the aim and steps followed, stability testing procedures have been categorized into the following four types.
- Real-Time stability testing
- Accelerated stability testing
- Retained sample stability testing
- Retained sample stability testing
Analytical Laboratory Services:
Provide Analytical testing services to pharmaceutical manufacturers, raw material suppliers, and product development partners.
The various Analytical Laboratory services provided are:
- Raw Material Testing (USP/NF, EP, JP)
- Finished Product Quality Control Release Testing
- Stability Testing and Storage
- Method Development / Method Validation
- Method Transfer / Method Verification
- Drug Release / Dissolution Testing
- Extractable / Leachable Testing
- Residual Solvents Testing
- Elemental Impurities Testing
Clinical Research Services:
Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. Clinical Research Services involve nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
The various services include:
- Clinical registration of new pharmaceutical products and medical devices, from phase I to phase IV, including Bioequivalence, Bioavailability
- Pharmacokinetic / Pharmacodynamic studies
- Statistical Analysis and Data Management as per ICH and GCP guidelines.
Regulatory Affairs Services:
Regulatory Affairs Consulting Services involve all aspects of clinical trial applications and marketing authorization applications for human medicinal products. The Services include full regulatory support from pre-clinical to post-marketing to manufacturers of Pharmaceutical Drugs, Medical Devices and Cosmetic products.
The typical Services include:
- All the Regulatory Registration functions of the Indian FDA - CDSCO ( Central Drugs Standard Control Organization, popularly known as the Drugs Controller General of India (DCGI) ) & NPPA ( National PharmaceuticalPricing Authority )
- The overseas FDA Product Registrations such as:
- Pre-IND and IND preparation and submission
- Pre- and post-IND and NDA meetings with the FDA
- Preparation and submission of NDAs, ANDAs and 505(b)(2) NDAs
Process Validation Services:
Process Validation is the most recognized and important parameter of GMPs.
Good Manufacturing Practice (GMP) A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
In pharmaceutical industry, Process validation of a process will ensure production of drug of reproducible quality. It includes the qualification of systems and equipment. The goal of the validation is to ensure that quality is built into the system at every step, and not just tested for at the end, as such validation activities will commonly include training on production material and operating procedures, training of people involved and monitoring of the system whilst in production. In general, an entire process is validated and a particular object within that process is verified.
The process validation services are aimed to provide documented evidence to pharmaceutical, biotech, API and medical device clients to ensure process and product monitoring via consistently producing a product that meets its predetermined specifications and quality attributes. This process validation goes for all aspects of manufacturing, filling, sterilizing and packaging.
The various services include:
- FDA Process Validation
- Process Performance Qualification (PPQ)
- Guidance for Industry Process Validation General Principles & Practices
- Process Validation Guidelines
- GMP Process Validation
Formulation Development Services:
A Formulation is the composition of a drug product that contains the active pharmaceutical ingredient (API) and other inactive ingredients. A good formulation must be manufacturable, chemically and physically stable throughout the manufacturing process and product shelf life. In addition, many quality standards and special requirements must be met to ensure the efficacy and safety of the product.
Formulation Development Services evaluates and determines a variety of parameters to arrive at the right formulation using the active pharmaceutical ingredient (API).
- Solubility of API in different media and solvents
- Excipient compatibility studies
- Dissolution of the active pharmaceutical ingredient (API)
- Accelerated Stability Services under various conditions
- Solid state analysis (polymorphs, particle size, particle shape etc.)
Analytical Methods Development and Validation:
Analytical methods development is aimed with the goal to rapidly test preclinical samples, formulation prototypes, and commercial samples.
There are five common types of analytical methods, each with its own set of validation requirements:
- Identification tests
- Potency assays
- Quantitative tests for impurities
- Limit test for the control of impurities
- Specific tests
The specific tests such as particle-size analysis and X ray diffraction are used to control specific properties of the active pharmaceutical ingredient (API) or the drug product.
The most widely used methods for quantitative determination of drugs and metabolites in biological matrices such as blood, serum, plasma, or urine includes Gas chromatography (GC), High-performance liquid chromatography (HPLC) ,Thin layer chromatography (TLC), combined GC and LC mass spectrometric (MS) procedures such as LC-MS, LC-MS-MS, GC-MS and GC-MSMS, techniques like NMR is used for structure identification.
Process Development & Scale-Up Services:
The competencies in Process Development include:
- Preclinical proof of concept studies
- Formulation development studies
- Conjugation chemistry optimization
- Development and optimization of supporting purification techniques
- Robustness and process characterisation studies
The Scale – Up services involves the procedure of transferring the results of R&D obtained on laboratory scale to the pilot plant and finally to production scale.