• Introduction
• API Development and Manufacture
  • Medicinal Chemistry Support
  • First in Man (Rapidd™)
  • Intermediate and API Supplies
  • Supporting Capabilities
• Solid State Services
  • Polymorph Screening Service
  • Crystal Engineering
  • Crystal Form Selection
  • Characterisation
  • Pharma Expert Witness
• Analytical
  • Method Development and Validation
  • Physical and Chemical Characterisation
  • Product Testing
  • Stability Testing
  • Facilities and Instrumentation
• Peptides and Proteins
  • GMP Peptide API
  • Custom Peptides
  • Immunograde Peptides
  • Chemokines
  • Site Specific PEGylation
    • Ligation Technology
    • Application to PEGylation
  • Facilities and Equipment
  • Quote
• Isotope Chemistry
  • Chemistry
  • Analysis
  • cGMP
  • Labels
• Biocatalysis
  • Biocatalysis Services
  • Biocatalysis Expertise
  • Enzyme Kits
  • Process Development
  • Chiral Building Blocks
  • Enzyme Screening
  • Fermentation & Molecular Biology
  • Purification
  • Enzyme Kit Quotation Request

Regulatory Support and Quality Systems

Almac Sciences deeply knows and understands the regulatory requirements for each phase of clinical development and country of filing. We provide data and support for the European, US and Japanese regulatory submissions:

• CMC
• IND & NDA
• IMPD

Quality systems and culture

Almac Sciences is committed to providing the highest standards of cGMP required by our clients.

Our Quality System is an integral part of our business and has been specifically developed to be compliant with ICH Q7 “ Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” as it relates to API and API intermediates.

It applies across all areas of our cGMP activities including process development, manufacturing, analytical and stability services and isotope labelling.

We operate in a culture of continuous improvement supported by internal and external audits. All GMP activities are closely monitored by our Quality Unit consisting of Quality Control (QC) and Quality Assurance (QA) departments, thereby assuring our clients of continued adherence to cGMP, specifications and regulatory compliance at all times. All GMP batches are released by QA.

Our staff receive regular training ensuring that developments and improvements are applied consistently throughout our company.

(Our staff training programmes ensure that our staff remain committed to GMP compliance and providing excellence for our clients).

Our Quality System and Analytical Services Laboratories are regularly audited by MHRA. In providing analytical support to a number of our clients we have been listed as a Contract Laboratory on a number of Manufacturers Authorisations for Investigational Medicinal products issued by MHRA.

Documentation

• Standards are established for all GMP activities in the form of specifications and protocols.
• All standards are approved by QA and by our customers, if required.
• Master documents, such as master batch records and specifications, are approved and controlled by QA.
• GMP products are released by Quality Assurance; the following certificates are approved and issued by QA:
  • Certificates of Analysis
  • Certificates of GMP compliance
  • Certificates of Origin (confirming compliance with TSE legislation)
• Standard Operating Procedures (SOPs) are available for all GMP activities and are controlled and maintained by QA. These SOPs govern all GMP activities throughout all GMP projects from material management through to packaging and shipping of the API.
• All GMP documentation is securely and safely archived for 10 years.