Your Turnkey Pharmaceutical Compliance Partner
Cold chain management
validation & Qualification
Cold chain products are time and temperature sensitive products that needs to be maintained at the required temperature to ensure product quality, safety and potency right from the point of manufacture to the point of administration. To ensure uncompromised cold-chain, the entire process, equipment and personnel should be effectively co-ordinated and managed.
Our Services include; Cold room design and installation, Design of a compliant cold chain vehicle, cold chain process and equipment validation, Cost and Risk Reduction Strategies, Managing supply chain from the cloud.
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages.
Our validation methodology have been developed on a risk based approach to meet cGxP defined standards and requirements; with our experienced validation consultants and Engineers, we have helped our clients developed some key project document, ranging from Validation Master Plans, User Requirement Specifications (URS), Functional Specification (FS) Design Specification (DS).
The development and registration of dossier for medicine is an important document which is submitted for review to regulatory agencies by Pharmaceutical Companies. We understand the role of this document to your company in the achievement and sustenance of your business goal. Our team of experts are experienced and vast to help your organization achieve this objective.
We will take the pains off you by helping to ensure the timely development of this key document with no error.
We understand regulatory requirements for product registration and will help ease the stress encountered during this process. We will save you time, money and get you your desired results. We are your partner in progress.
Medicinal Products, the production and storage facility, the raw materials and the equipment used in producing them are classified critical to product’s safety, quality and efficacy. As such, there are some minimum global requirements and best practices to be met by regulators and other key stake holders.
Our Auditing team offer cGxP (current Good Manufacturing, Clinical, Storage, and Laboratory Practice) audit services to our respective clients to ensure that all relevant regulatory requirements are met.
We provide a complete audit solutions for all kinds of Pharmaceutical Products such as active pharmaceutical ingredients (API), drug products, excipients, over-counter products, vaccines and vitamins. This is done by adopting a risk based approach
Implementing a quality management system as much as an art is a science. It takes data and records but also requires the ability to engage people. It involves a deliberate methodological approach but also requires some level of dynamics and creativity. QMS as popularly referred to is the bed rock of an organization’s demonstration of excellent performance to the requirements of key stakeholders. It is a management system to direct and control an organization with regards to quality.
We understand this at Damkrestals international Limited. We will help you through the entire Implementation and continuous Improvement of the system to ensure; Improved Product and Process Quality, Good organizational governance, Increased international recognition, Improved customer retention and acquisition, Reduce cost and Increase Productivity, Increase your sales volume and market gains.
With Our Expertise, Your Compliance Worries Are Over
….Your ever reliable Pharmaceutical compliance partner……