Alpine Quality Consultants provide guidance & support for compliances by highly qualified, experienced and professional Advisors & Experts with respect to National & International Regulatory standards & guidelines. We support our clients to prevent & resolve compliances problems:

Guidance and Compliances on

Drug Act & Cosmatic Act 1940 – Manufacturing & Testing

• Manufacturing Licence on Form 25, 25-A, 25-B, 25-F, 28, 28-A, 28-B
• Licence for the purpose of Test Examination Or Analysis on Form 29
• Manufacturing Licence for Large Volume Preparations,Sera & Vaccines on Form 28- D
• Blood Banks Licence on Form 28-C
• Approval of Testing Laboratory on Form 37 
• Inclusion of items in Drugs Mfg. Licence.
• Renewal of Manufacturing Licences
• Renewal of Manufacturing Licence, Blood Banks, Large Volume Parenterals, Sera-vaccines and Approval of Testing Laboratories
• Issue of WHO-GMP Certificate.
• Issue of COPP
• Issue of good Manufacturing Practices (GMP) Certificate
• Issue of Non-Conviction Certificate
• Issue of Performance Certificate
• Issue of Validity Certificate
• Issue of GLP Certificate
• Free Sale Certificate

Drug Act & Cosmetic Act 1940 – Sales & Distribution

• Grant of Licence on Forms 20-B, 21B, 20-G, 20-D
• Grant of Licence on Form 20-BB/21-BB
• Grant of Licence on form 20, 21, 20 F, 20 C, 20 A, 21-A, 20, 21, 20-F, 20-C, 20-A, 21 A
• Renewal of Sales Licences.

Licence and Permissions as per MDR (Medical Device Rule) 2017 effective from 01^st January 2018

• Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017 on Form MD-2
• Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device on Form MD-5
• Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device on Form MD-6
• Licence to Manufacture for Sale or for Distribution of Class C or Class D on Form MD-9
• Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device on Form MD-10
• Permission to conduct Clinical Investigation on Form MD-23
• Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device on Form MD-25
• Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device on Form MD-27 
• Permission to Import or Manufacture New In Vitro Diagnostic Medical Device on Form MD-29
• Certificate of test or evaluation by the Central Medical Device Testing Laboratory on Form MD-31