REGULATORY AFFAIRS

Considering continuous transformations in cGMP & cGLP regulations over the past decade, Mepro has developed a strong team of regulatory affairs who are capable of handling audits from MoH and compiling dossiers as per ICH / ACTD / ECTD guidelines of various countries. We have by now handled many audits with great efficiency & excellence which has given us a comprehensive understanding of the ever changing regulatory environment. We continue to invest in our staff & workforce in the areas of training & updating of best practice issues. Mepro has by now compiled & submitted more than 225 dossiers and entered into supply agreements or licensing opportunities thereby.

FORMULATION & DEVELOPMENT

At Mepro, we recognize the importance of our clients' requirements to develop robust formulations and tactically offer all the extensive preformulation studies relevant to selecting and advancing optimal dosage forms. Our goal is to overcome technical challenges to develop products with enhanced bioavailability.

While working with our clients, we offer and evaluate the following parameters when developing and manufacturing certain dosage forms.

  • Pre formulation studies & pilot scale batches
  • Process optimization & their validation activities
  • Analytical method development & validation for in house procedures like assay, dissolution, related substances & residual solvent
  • Stability Studies as per ICH guidelines
  • Facilitating commercialization of products by transferring technology to manufacturing location.

FORMULATION SERVICES AND CAPABILITIES

  • Optimization of existing formulations
  • Process development for selected dosage forms
  • Novel formulations for improved delivery of existing dosage forms
  • Controlled release and sustained release formulations

At Mepro, core teams of pharmacists are backed by excellent infrastructure & equipments. Pilot scale batches are made & analyzed with equipments like:

1. Rapid Mixture Granulator
2. Fluid Bed Dryer
3. Roll Compactor
4. Sifter
5. Compression Machine
6. Bilayered Tablet Compression Machine
7. Planetary mixer
8. Capsule filling machine
9. Blistering machine
10. Auto Coater
11. Stability Chambers
12. HPLC
13. UV Spectrophotometer
14. Dissolution Apparatus
15. GC
16. FTIR