CRMO Pharmatech Pvt. Ltd - Pharmaceutical Project Management

Selection of the correct outsourcing partner
1. Key factors required for the supplier:

2. Outsourcing competitiveness,

3. Geopolitical, cultural and economic circumstances,

4. Knowledge/ exposure on International regulatory benchmarks,

5. Manufacturer’s proficiency over CRAMS model.

6. Track record of the potential partners.

Defining outsourcing agreements
This is one of the most critical challenges to overcome as the goals and incentives of the customer and supplier are different: The customer wants highest quality, more flexibility and lowest cost arrangement, whereas the supplier wants higher margins, firm commitment periods and standardized quality standards.

Managing timelines and preventing Overruns
It is critical that a pharmaceutical company is able to successfully develop, launch and market new products to generate the premium returns expected by shareholders and investors. High investment in the R&D initiatives, pressures to reduce prescription costs, decline in product lifecycle, increased regulatory scrutiny, intensive generic competition and post patent expiry are few of the main drivers which compel a pharma company to introduce the new products in the market at the earliest and ensure maximum returns. Any planning gone off target mounts to big revenue losses.

Logistics and supply chain management in post approval phase
Ensuring a consistent supply of the product in terms of quality and quantity, post approval, is a major challenge for the International companies. Coordination across suppliers and catering to small and volatile market demands, makes it further challenging.