quality control

Mickle performs analytical testing at all stages of Formulation & Intermediate manufacturing process, starting from the initial release of raw materials to in-process testing to final release of finished products with a Certificate of Analysis (CoA).

An independent Analytical Research & Development (AR&D) department develops and validates the Analytical Methods and also supports R&D for working standards, impurities, etc. The development is then systematically transferred under set protocol to the quality control department for regular analyses and release. In some cases these developments are received from the clients itself for contract manufacturing projects.

• We have fully equipped QC Laboratories with state-of-the-art instrumentation, such as XRD, HPLC, GC, FT-IR, UV, PSD by Laser Diffraction, and several others
• Our QC Laboratories are backed by a team of highly trained and skilled chemists
• All kinds of stability studies are performed by our QC Laboratories i.e. Long Term, Intermediate and Accelerated as per ICH guidelines

• Quality

  Regulatory Affairs

  Our regulatory team is qualified & experienced to comply with regulatory requirements for preparing & filing Drug Master Files in different countries & supporting customers to ensure their timely Dossier approval.

  • Company has over 150 regulatory filings across the globe to its credit with regulatory authorities of USA, EU, Japan, Australia, Canada, Korea, Taiwan, China, Russia, Brazil Mexico, and several other countries
  • Team regularly interacts with country specific regulatory authorities to update its knowledge & ensure appropriate compliance
  • Team supports customers for regulatory submissions and responding to regulatory queries in a timely manner

• MileStone

  

quality assurance

Mickle firmly believes in its ‘Quality Management Systems' established in accordance with International Conference on Harmonization (ICH) and other regulatory guidelines issued from time to time as an integral tool for consistency and reliability to achieve customer satisfaction.

With our presence in the regulatory markets, we take adequate care to develop, create and execute proper equipment qualification, cleaning validation and process validation as per set protocols to ensure full regulatory compliance to our clients and the authorities. We follow stringent and updated guidelines; perform the most robust testing methodologies to ensure our product is of the highest quality when it leaves our site and reaches its destination.

Mickle firmly believes in its well developed and executed ‘Quality Management System' as an integral tool for consistency and reliability to achieve customer satisfaction and regulatory compliance for its products and services.

With over a decade of experience, a nurtured and mature cGMP culture is meticulously followed by every Mickle personnel at all times.

• Have a long and successful history of audits by leading drug discovery & generic pharma companies
• Assures top quality with its perfected integrated quality management system which is certified by ISO 9001 since 2003
• Cares for the environment and is certified by ISO 14001 since 2008
• Values human life and is certified by OHSAS 18001since 2010

regulatory affairs

Our regulatory team is qualified & experienced to comply with regulatory requirements for preparing & filing Drug Master Files in different countries & supporting customers to ensure their timely Dossier approval.

Team supports customers for regulatory submissions and responding to regulatory queries in a timely manner.

Team regularly interacts with country specific regulatory authorities to update its knowledge & ensure appropriate compliance.

Company has over 150 regulatory filings across the globe to its credit with regulatory authorities of USA, EU, Japan, Australia, Canada, Korea, Taiwan, China, Russia, Brazil Mexico,  and several other countries.

• Quality

  Regulatory Affairs

  Our regulatory team is qualified & experienced to comply with regulatory requirements for preparing & filing Drug Master Files in different countries & supporting customers to ensure their timely Dossier approval.

  • Company has over 150 regulatory filings across the globe to its credit with regulatory authorities of USA, EU, Japan, Australia, Canada, Korea, Taiwan, China, Russia, Brazil Mexico, and several other countries
  • Team regularly interacts with country specific regulatory authorities to update its knowledge & ensure appropriate compliance
  • Team supports customers for regulatory submissions and responding to regulatory queries in a timely manner

accreditations

Mickle performs analytical testing at all stages of Formulation & Intermediate manufacturing process, starting from the initial release of raw materials to in-process testing to final release of finished products with a Certificate of Analysis (CoA).

An independent Analytical Research & Development (AR&D) department develops and validates the Analytical Methods and also supports R&D for working standards, impurities, etc. The development is then systematically transferred under set protocol to the quality control department for regular analyses and release. In some cases these developments are received from the clients itself for contract manufacturing projects.

• We have fully equipped QC Laboratories with state-of-the-art instrumentation, such as XRD, HPLC, GC, FT-IR, UV, PSD by Laser Diffraction, and several others
• Our QC Laboratories are backed by a team of highly trained and skilled chemists
• All kinds of stability studies are performed by our QC Laboratories i.e. Long Term, Intermediate and Accelerated as per ICH guidelines

• Quality

  Regulatory Affairs

  Our regulatory team is qualified & experienced to comply with regulatory requirements for preparing & filing Drug Master Files in different countries & supporting customers to ensure their timely Dossier approval.

  • Company has over 150 regulatory filings across the globe to its credit with regulatory authorities of USA, EU, Japan, Australia, Canada, Korea, Taiwan, China, Russia, Brazil Mexico, and several other countries
  • Team regularly interacts with country specific regulatory authorities to update its knowledge & ensure appropriate compliance
  • Team supports customers for regulatory submissions and responding to regulatory queries in a timely manner

• MileStone