Articles

Pharmaceutical Product Development – A Unit of Planning and Development of Drug

by John Smith Digital Marketing Expert
Health professionals are made aware of the process by which medicines and medical equipment that are used daily in medical practice reach the market. Current trends regarding this process are exposed.

This branch of science is based on various scientific disciplines, particularly molecular and cellular biology, biochemistry, genetics, immunology, and computer science.

Each product used by medicine goes through, broadly speaking, different stages:
  • Preclinical studies.
  • Clinical studies.
  • Post-marketing studies.
  • Preclinical studies
The product is closely monitored and is only administered to hundreds of patients.

Once these studies are concluded, the product file with the information generated during them is submitted to the consideration of the country's Regulatory Agency, which reviews it and determines whether the product should be placed on the market or not.

The development of a product of adequate quality in a short period of time constitutes a critical point in the pharmaceutical area. The finished product's planning and development are meticulously carried out and in permanent contact with the client, thus ensuring a final product that meets the pre-defined requirements and their needs and expectations.

Pre-formulation

In Pharmaceutical product development, each drug and excipient follows an appropriate pre-formulation characterization, allowing identifying the best development strategy for each drug or health product.

Services
  • Pre-formulation;
  • Screening of excipients;
  • Evaluation of the compatibility between various components of the formulation.
  • Development and Production
Each drug is unique. Pharmaceutical product development pilot unit is prepared for the production of small batches of non-sterile solid, semi-solid, and liquid pharmaceutical forms, in accordance with the requirements of the Good Manufacturing Practice.
  • Galenic development of new products;
  • Formulations optimization;
  • Production of solid, semi-solid, and non-sterile oral liquid forms on a pilot-scale;
  • Support in scale transfer;
  • Definition of processes and controls in associated processes.
Production

The Production Unit is directed towards innovative formulations in the following areas:
  • Medicines for human use;
  • Veterinary drugs and products;
  • Food Complements;
  • Medical devices;
  • Cosmetics;
  • Personal hygiene products.
Pharmaceutical product development provides a full make-to-order service for partners looking for flexible, superior quality from a trusted manufacturer capable of producing dosage forms to their specifications.

Pharmaceutical product development has a high-performance Production Unit whose effectiveness is valued by the continuous improvement and adaptability of the products and o partners' demands.

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About John Smith Senior   Digital Marketing Expert

343 connections, 4 recommendations, 973 honor points.
Joined APSense since, June 14th, 2012, From Delhi, India.

Created on Jan 27th 2021 21:46. Viewed 357 times.

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