Services

COREALIS Pharma offers «turn-key projects», i.e performing the complete project development steps of a finished product. We can also take on specific projects and perform one or several phases of the product development process.  We have a very flexible approach and pride ourselves in providing superior personalized services with fast project start-up and 100% on-time delivery. 

FORMULATION & PROCESS DEVELOPMENT

Proof of Concept

 Feasibility study for the development of a solid dosage form of an active ingredient

Pre-Formulation

 Compatibility study of the excipients with the active ingredient

 Characterization of the active ingredient using analytical techniques such as SEM, XRPD, DSC, TGA, NMR, HPLC, and LC-MS, as well as physical testing methodologies such as the determination of particle size, distribution, compressibility, flow, and stability; in order to provide practical insights and quickly optimize the formulation.

Formulation Development

Tablets, capsules, and granules

New chemical entities, biotechnology products, and controlled substances

Immediate or modified release dosage forms

- Gastric protection

- Sublingual (orally dissolving tablets)

- Effervescent

- Delayed or sustained release

Formulation for patent approval

Evaluation of formulations

Process Development

Development of the manufacturing process of the product: direct compression, dry or wet granulation, encapsulation, extrusion/spheronization, spray drying, and coating

Determination of the critical manufacturing steps and parameters

Establishment and justification of the finished product specifications

Process implementation justification of the tests and specifications to be respected during production

Overview of Services

Analytical method development performed within the guidelines of regulatory agencies

Rapid results on the chemical and physical properties of the raw materials and finished products

Analytical results are compiled and delivered quickly, precisely, reliably and treated according to the applicable regulatory requirements

General Analytical Services

Pre-formulation analysis

Development, optimization, and validation of the analytical methods for active ingredients, excipients, and finished products:

- Assay

- Impurities (Related Substances)

- Content and Blend Uniformity

- Dissolution (UV, HPLC)

- Degradation products (including forced degradation)

- Cleaning validation

Stability studies according to the ICH guidelines

- 25±2°C / 60±5% RH

- 30±2°C / 65±5% RH

- 40±2°C / 75±5% RH

Compatibility studies between active ingredients, excipients, and packagings

Analysis of controlled substances

Specific Analytical Services

Identification and quantitation of impurities and degradation products

Photo stability studies

Microbiological testing

Analysis of the polymorphic form(s) of the active ingredients

Determination and particle size and distribution

Permeability studies (PAMPA or Caco-2)

Solubility determination

Water content determination

Evaluation of Active Ingredients

Selecting suppliers, evaluation of prices, availability, and delivery dates

Evaluation of manufacturing processes and conditions, and quality of active ingredients

Definition and justification of specifications of the active ingredients

COREALIS Pharma performs the tablets and capsules manufacturing for clinical trials, the submission to regulatory agencies, and, if necessary, performs the transfer of the products and processes to a large scale manufacturing site. These transfers are carefully planned, structured, documented, and the work is supported until final approval and the manufacturing of the commercial batches.

Services

Manufacturing of R&D batches to reduce development time

Scale-up of manufacturing processes for the production of clinical batches and submission batches
Troubleshooting

Manufacturing of clinical batches

- Manufacturing of clinical batches for exploratory studies (IND)

- Manufacturing of clinical cGMP batches for phase I, II, and III and bioequivalence studies

- Manufacturing of cGMP batches for submission to regulatory agencies

- Manufacturing of cGMP placebos identical to the active products

COREALIS Pharma recognizes the uniqueness of each Client and their projects. Frequent communications, interactions, and follow-ups with clients are of the utmost importance. Clients will have the possibility to access in real-time the information, the data, and the documents related to their projects. Maintaining appropriate contacts with Clients and providing them with a maximum amount of information on the progress of each project is essential to ensure success. COREALIS Pharma assists during various steps of the development or manufacturing of the product by offering professional consulting services and support with regulatory agencies at the required time and location.