Pharmaceutical Validation Contractors and GMP Contractors

PharmOut is an international contracting company offering our outsourced contracting services at short notice at competitive rates. So if you are looking for GMP or Validation contractors at short notice for short or long durations, why not give us a call.

We operate throughout the world and have an office in Singapore which services the Asia Pacific region. PharmOut prides itself on the practical application of regulations ensuring compliance in the manufacturing world.  Our professional staff have experienced most of the problems that can occur in the Pharmaceutical, Medical Device and Biotechnology manufacturers.

As Pharmaceutical professionals we have extensive knowledge of current compliance regulations and keep abreast of any changes to these to ensure that our customers are always compliant.

We work with multinationals companies and small companies just starting out.  Typically we deal with Quality Assurance, Validation Managers and Engineering Managers within pharmaceutical companies looking to enhance business profits and export to international markets by ensuring that all of their staff understand and work towards becoming compliant.

The services we offer are:

Training on GMP/GLP Compliance

• Training on PIC/s and other GMP Quality Management Systems regulations.
• Practical recommendations and advice on implementation of ISO 9001 for Pharmaceutical or ISO 13485 for Medical Device Quality Management Systems, Policies, SOP and Forms.
• International Regulatory Auditing assistance to obtain approval from the following international regulatory authorities (FDA, HSA, WHO). Download our Audit Readiness brochure now
• Expert coaching on 21 CRF Part 11 and Annex 11 compliance to FDA requirements
• Managing pharmaceutical and food manufacturing facility projects to ensure regulatory compliance.
• Customised training targeted at than identified need within your company, however we do provide specific training for ISO 13485.
• Process Validation Training in Pharmaceutical and Medical Device companies to comply with HSA, WHO and FDA regulations.
• Equipment Validation Training to international regulatory standards and in accordance with current Good Manufacturing Practice.
• Cleaning Validation Training for pharmaceutical and medical device manufacturing facilities.
• Computer System Validation Training to comply with GAMP and 21 CFR Part 11 or Annex 11 requirements.

People

• Professional Trainer to go to your site to teach your employees about GMP compliance.

• We have Pharmaceutical Engineers, GMP Consultants, Validation Contractors and Technical Document Writers available at short notice and at competitive rates.

Drug Registration

• We can help you prepare the dossiers necessary to submit drugs for registration with international regulatory bodies but our focus is Singapore, Australia, South Africa and USA.

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