Baikunje Consultancy

Baikunje Consultancy To provide support for Pharma/Biopharma/CROs for "Achieving transparency in Quality and compliance" by utilising Quality and Compliance tools effectively.

BK Consultancy provides :- Consulting and Training to Pharmaceutical, Biopharmaceutical companies and CROs on:
a)Quality and compliances- CMC and Clinical. b)Quality Audits –GMP and GCP. c)Gap assessments for Products, manufacturing facilities and CROs. d)Investigations, CAPA and support for FDA, EMA, WHO observations
e)Support for responding 483s, Warning/Untitled letter, WHO-NOCs and EMA inspection findings. f)Support for assuring data integrity and data reliability. g)Regulatory compliances and filing for Stem cells and other Biological products. h)Conducting training on GMP, GLP, GTP, GDP, Quality tools and compliances. i)Validations-Protocol/report writing, review and execution guidance for GMP and GLP compliances
j)Technical due diligence for Pharmaceutical and Biopharmaceutical companies.

Address

Bangalore

Opening Hours

Monday 8am - 8pm
Tuesday 8am - 8pm
Wednesday 8am - 8pm
Thursday 8am - 8pm
Friday 8am - 8pm
Saturday 8am - 8pm

Telephone

+919916412448

Website

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