Eclectic: Assisting Pharma Businesses across the Product Lifecycle

Minal Yadav,Director & Consultant

Minal Yadav

Director & Consultant

Indian pharmaceutical industry has taken a giant leap in the global market. Majority of large and medium pharmaceutical organizations are expanding and reaching out globally to fulfil the growing demand of medicines. These companies are ready to export in the highly regulated markets. Although, they have a highly talented team of formulation developers, the firms lack exposure to the guidelines of the various agencies.

Moreover, the interpretation of the guidelines requires a dedicated team as the same keeps evolving. Headquartered in Thane Mumbai, Eclectic has a team of regulatory experts, who can be of great help to many such companies. Eclectic is adept in providing global expertise to these companies with sound technical knowledge and save lot of time and cost to these companies.

Established in 2013, Eclectic comprises of group of professionals hailing from the Pharmaceutical Industry carrying 35 years of experience across multiple segments of the industry. The firm is centred on a strong network across various sectors within the industry and has been established by highly qualified and experienced personnel who consistently deliver top-quality results,
thereby making things possible for the clients globally. Eclectic serves small and medium enterprises who are involved in manufacturing and marketing of active pharmaceutical ingredients, drug products (sterile & non- sterile) and packaging materials. The company has expertise in various therapeutic areas like Oncology, ARV's, Anti-Asthma (Nasal sprays and metered dose inhalers), Antimalarials, Antibatcerials, Antivirals, Cardio-vascular, Dermatology, Hormones (Women's health) and many more. Eclectic exhibits its expertise in International Regulatory Affairs, IPR Services and Quality Functions.

Eclectic works with clients on a retainer ship model and on project basis. The organization has contracts with various formulation development companies and API manufacturers. Scope of job includes providing advice/guidance on various aspects starting from development to filing of CTDs, DMFs and various dossiers. Not to forget to mention, Eclectic takes care of the confidentiality of documents and information. Eclectic also has the requisite expertise for electronic CTD submissions, GMP audit preparations of various API and formulation manufacturing facilities.

Eclectic comprises of group of professionals hailing from the Pharmaceutical Industry carrying 35 years of experience across multiple segments of the industry

Eclectic is a fairly young organization and has completed some of its most diversified and specialized projects. The completed projects include ANDA submissions of sterile formulations, CTD writing for MHRA, CTD review for Europe region, writing clinical and non-clinical overview for Europe region, KFDA submissions, US-DMF review and GAP analysis, GMP registration at COFEPRIS Submissions for emerging markets like entire South East Asia, Jordan, Iran, Tajikistan, CAPA resubmission & pre-audit for Ukraine, and writing of pharmaceutical development reports as per QbD. Some projects under execution are Patent landscaping, eCTD submission for Europe region, US-DMF writing and writing of pharmaceutical development reports (QbD).

In the years to come, Eclectic aims to provide comprehensive Pharma Solutions for various challenges faced by its clients, right from formulation development to the marketing of the product.