Allos is leveraging Causal-AI to make novel formulations of complex drugs more accessible to patients. Our proprietary software, combined with real world patient data allows us to rapidly iterate through formulations, forecast pilot study outcomes as well as clinical endpoints.

Consultant Generic Pharmaceuticals all aspects with over 35 years of association with the industry.

Lyrus is a company based out of Bangalore with a Formulation research and development for novel and new drug delivery mechanism in Oral dosage forms, liquid orals, Eye & Ear Drops. A center for product development in Hoskote Karnataka for the EU/Australia/South African Markets.

A Niche Generic pharmaceutical company with focus on unmet needs. Assist them in portfolio selection for the UK and EU Generic markets, product development and contract manufacturing. Products currently under registration Hydrocortisone tablets 10/20mg, Flucloxacillin suspension 125mg/5ml , 250mg/5ml Sugar Free 100ml bottles, Penicillin V Pottasium 125mg/5ml and 250mg/5ml sugar free suspension 100 ml bottles. For more details visit our website www.novelgenix.com

In the year 1997 started a collaborative partnership with a UK company with a view to register generic products in the United Kingdom, with second site of manufacture based in India with specific emphasize to Beta lactams and was instrumental coordinating an MHRA style audit and approval obtained for this facility in the year 1999. Developed a low profile CRO to a ICH guideline oriented facility for conducting BA/BE studies, which has been currently acquired by Paraxel of the U.S.A. and conducted a Phase II-A clinical trial using them as a CRO for a patented drug delivery system at Nizam's Institute of Hyderabad, for submission in U.K.Also engaged in obtaining dossiers from a European based company and develop the dossiers for full submission in the EU by way of assisting validation data's, stability studies, and clinical comparative bioequivalence. 18 products are presently in pipeline and or in ongoing submissions under the Mutual recognition procedure.

I consult for product portfolio management with Aurobindo Group, and I am looking for UK MHRA approved oral dosage form units for contract manufacture of generic products. The recent acquistion of Crossbow from Actavis by the Group, has opened up avenues for more contract manufacturing, I am looking at Steroidal dosage form manufacturers, Syrups and suspension in botltles/sachet, granules for syrup in sachet filling, facilities which have EU approvals are welcome to be in touch with me.

Outsourcing of generic Oral dosage form from third party manufacturers with EU GMP/US FDA approved facilities, In licensing of generics, site audits for GMP compliance, cost reduction on both finished dosage forms and API/excipients. Advice on faster regulatory process of licensing dossiers. Tech transfer to third party manufacturer and coordinating validaton aspects of finished dosage forms.

A Pharmaceutical professional engaged with the generic pharmaceutical industry for over 25 years, with all aspects of managing a generic pharmaceutical company based out of Europe and India. Have developed more than 125 generic molecules independently in the formulation oral dosage form segment during the last 15 years.Extensively connected with the bulk drug and formulation of pharmaceutical dosage forms.Area of expertise: contract manufacture, pricing and commercial negotiations, site audits, dossier compilation, research and development, technology transfer, outsourcing and vendor development. and ability to manage a large team of personnel in all aspects of the generic pharmaceutical industry.

Established a consultancy link based in Mumbai under the name of Bullfinch Exports with Duphar Interfran in the year December 1992and also assisted them in finding a financial partner for their specialty enzyme division (Fermenta Pharma Biodil Ltd) with manufacturing facility based in Kullu Manali Himachal Pradesh which was then the pioneer to manufacture enzyme based catalyst Penicillin G Amidase in India for Captive consumption by Semi synthetic penicillin API substance manufacturers. The company has since expanded in the Biocatalyst Platform developing newer version of active substance using Biocatalyst. Also assisted the Duphar Group in India to improvise their yields in the manufacture of 6 APA and other Beta lactam derivatives through an Italian collaboration.Started my own Imports organization based in Chennai in the year 1995 under the name and style of Dandik Impex to import life saving drugs under agency agreements and Technical collaborations was instrumental to bring in Rotex Medica of Germany to promote their Methylprednisolone sodium succinate injectable which was only second to Solumedrol of PharmaciaAssisted key trading companies in India/UK to register their range of Oncology products in the erstwhile USSR with specific emphasize to Ukraine, Lithuania, Estonia, and Crimea

Acquired as a part of the Group companies diversification)COUNTRY HEAD; Was promoted as Country Head in Copenhagen with the group's acquisition of a Bulk Drugs trading facility under the name and style of Marsing and Company A/S with six satellite offices around the world and coordinating Bulk drug purchases and marketing. From the year 1989 at the time of acquisition the company was making a net loss of USD 800,000/- which was turned profitable by keener purchases and product diversification and I was instrumental in turning the company into a profit making organization the very first year and managed till August 1991 when the Company was making net profits of USD 1.2 Million on a Global sales of USD 52 Million. Development of European Drug master file for 30% percent of the products traded at Marsing.Held various senior level postings in the Group companies with respect to management and affairs of the total vertical integration of the Group companies from Bulk Drug to formulations to wholesale to retail.Established Supply chain management for the group's 3 manufacturing plants (2 based in London & 1 in Ashford, Kent)

As a Director representing the Board, after acquisition of Marsing from Picheneyin the year 1989.Have represented in all management function of this bulk drug trading company until 1991

Responsible of formulation imports from third world countries for exports to East Africa.Instrumental in group's project for setting up a Pharmaceutical Formulations facility in Ashford, Kent under the name of Letap Laboratories Limited.Have thorough knowledge of import export trade and have undergone a course conducted by London Chamber of Commerce and Industry during my tenure.Assisted the same group in their procurement and logistics as a Company Director after their Acquisition of Regent Laboratories Ltd in the late 1987 was instrumental in developing DMF oriented sources for API substances for their generic formulations and also participated in the product development area in developing newer generics which were likely to come off patent.

Was instrumental in designing pouch-packing machines for condoms, which were assigned to LRC India as a turnkey project for Vietnam in the year 1984.Fully conversant with CAM operated packaging linesCollaboration with LRG UK manufacturing Contraceptive condoms. Engaged in supervisory capacity in their packaging operations

Developed novel coating technologies for phytochemical products including aqueous coating to retain properties of dissolution profiles.Managed independently a bottling line of Woodward's Gripe Water and conversant with the entire operation of liquid bottling line.Key Areas of expertiseGeneric Pharmaceutical product development - Oral dosage form.Regulatory Affairs inclusive of Tech transfer for second site of manufacture, validation documentations, analytical documentation scrutiny, and submission to the MHRA in the UK.Oral dosage form Site Audit compliance to cGMP guidelines.Have been instrumental in getting seven Oral Dosage Form manufacturing facility in India the Coveted MHRA approval.Developed an Innovative drug delivery mechanism for Metered dose inhalers, and IP grants in South Africa, New Zealand for the same. EU IP pending for grant by end of the year.Independently worked on a phase II A clinical trial for multi dose double blind double dummy study on Salbutamol versus Ventolin Evohaler. Fully conversant with clinical studies relating to Metered dose inhaler and oral dosage form Bio Equivalence studies.Developed a process patent for Innovative methodology to produce Instant Black tea extract first of its kind with aroma trapping and cyclone spray drying.Fully conversant with all activities relating to Marketing authorization in/out licensing, Technical Agreements for contract manufacturing, Supply chain management and independent ability to draw contracts for Supply agreement and negotiating product supply chain for the competitive EU generic pharmaceutical market. Hands on contact with Pharmaceutical Majors in India, the Middle East and the United Kingdom, to develop outsourcing and supply chain contract management.Independent ability to manage Regulatory Affairs staff, procurement of Raw materials and excipients, and liaison with competent authorities.