Assignments

Strategy

STRATEGY

· Advised large UK based funding organization for end to end strategy for corporate structure , development to supply for 3 year long acting contraceptive implant

· Designed an India market entry strategy for a US based , USFDA approved , patented , micro-endoscope cum biopsy device company (including market analysis/study, corporate structure analysis and finalization, defining the fastest regulatory pathway & recruitment of key positions ).

· Onsite business transformation for UK based manufacturing company with all major departments in scope.

· Provided Public / tender market/ Localization strategy to large MNCs, NGO and startups in view of Make in India policy for their specialty products.

· Advised vaccine filling CMO on the partner selection strategy for COVID -19 vaccine.

· Advised celebrity dermatologist regarding nutraceutical product range sourcing change strategy, deployed pharma MBA interns for market research, social engagement and online sales channel.

· Helped with the legal strategy on a product patent protection litigation which was won by our side, a landmark HC Judgement

· Advised US based company for tech transfer of nanotechnology based eye drops

· Advising an engineering vison system and barcoding company to enter pharma sector on larger scale

M&A, Licensing & Others

P M&A, LICENSING AND OTHERS

· Pharmaceutical formulation , API & Intermediate plants & businesses acquisition and divestiture , minority , majority 100%

· Successfully assisted Unlocking value via divestiture of non core brands

· Supervised in and out-licencing of patented products

· Assisting a small molecule companies to in-license bio tech products.

· Nutritional/OTC Company to market their nutritional & OTC products portfolio to global markets

· Advised divestment and handover of multi country approved export focussed formulation plants

· Advised two India based CDMOs and one African CDMO on voluntary in-licencing strategy of patented COVID- 19 oral therapies and others opportunities.

· Targeted biosimilar biologics development , investment funding, supply chain.

Due Diligence

Vendor screening and contract award for conducting due diligence of large multi facility ( 8 plants) API and intermediate company for one of the Big 4 management conslttants’s international investor, completed in 5 weeks flat during COVID lockdowns. Prepared greenfield plant team to close gaps and face ROW regulatory inspections and also mock inspections for PIC/s Evaluation of list of chiral compounds products for in-licencing and setting valuation based on the time and gaps Multiple finished product facility divestiture / acquisitions /contract awards Warehouses for CFA audited and upgraded for global compliance norms Supply chain integrity due diligence Intellectual property eg counterfeits identification, training of government enforcement agencies , setting up program for anti diversion

Projects

Turnkey pharmaceutical plant project BOT ( build –operate-transfer) executed. Upgrade of older facilities to cGMP with cost effective approach Co-development of ERP and barcoding integrated software solution for export compliance 15 CMO rationalized to 5 CMO sites 90% with USFDA /EU certification , multiple tech transfers and no break in supply Defined User Requirement Specifications and conceptual designs for setting up dry powder injectable unit Rectified and retrofitted equipment for improved pellet coating coverage via SME for a pharmaceutical exporter Tender business was being lost and so designed a custom software to capture tender terms from any corner of the country , customize the delivery on special lines at speed to increase business multifold Global product artwork design to print outsourcing partner implemented successfully with huge volume processed 100% localization of imported products

Information Technology

INFORMATION TECHNOLOGY

• Govt. tender management system design for multiple customers , products , locations , sources spec to crash the lead time from months to days

• Scalable & Transferable device regulatory application system design

• Artworks management system design for all functions of company upto external printer

• ERP upgrades for many operational modules . Oralcle based, 21 CFR compliant system.

• Barcoding system improvement & integration for product for multiple markets , SKU s

Human Resourses and Liason

Pharma policy shaping and engagement of the government and non-government bodies Recruitment of key managerial personnel for specialized roles, bringing performance culture with positive team spirit Skill development modules for Industry developed and implemented in pharma companies form job description to SOPs Capacity building for cold chain management by one of the state governments Advised an NGO who wanted to build high paying career for low income background science graduates in pharma sector